Espion

GUDID 00850594007561

E3 System; with Non-Xenon ColorDome and 23" Monitor is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D315-1-1-CDNSL-23-N-N

DIAGNOSYS LLC

Electroretinograph

• Primary Device ID: 00850594007561
• NIH Device Record Key: ec7b3355-0be8-4fbd-8fa4-5bb3ab02c724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Espion
• Version Model Number: D315
• Company DUNS: 131488467
• Company Name: DIAGNOSYS LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850594007561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863956

FDA Product Code

• GWE: Stimulator, Photic, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

On-Brand Devices [Espion]

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• 00855730007139: Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mi
• 00855730007122: Cart-only, no control unit, no power unit, with 27" Monitor is a clinical and research visual el
• 00855730007115: Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual
• 00855730007108: Profile System; with 27" Monitor is a clinical and research visual electrophysiology system that
• 00855730007092: Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual
• 00855730007085: Profile System; with 32" Monitor is a clinical and research visual electrophysiology system that
• 00855730007078: Cart-only, no control unit, with 23" Monitor is a clinical and research visual electrophysiology
• 00855730007061: Profile System; with Non-Xenon ColorDome is a clinical and research visual electrophysiology sys
• 00855730007054: Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with tabl
• 00855730007047: Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with table stand & exten
• 00855730007030: Profile System; with 23" Monitor and ColorBurst and Mini OLED with table stand & extendable arm
• 00855730007023: Profile System; with 23" Monitor and Mini OLED with table stand & extendable arm is a clinical a
• 00855730007016: Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand & extendable arm
• 00855730007009: Profile System; with 32" Monitor and Mini OLED with table stand & extendable arm is a clinical a
• 00850594007998: Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with exte
• 00850594007981: Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with extendable arm is a
• 00850594007974: Profile System; with 23" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical
• 00850594007967: Profile System; with 23" Monitor and Mini OLED with extendable arm is a clinical and research vi
• 00850594007950: Profile System; with 32" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical
• 00850594007943: Profile System; with 32" Monitor and Mini OLED with extendable arm is a clinical and research vi
• 00850594007936: Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with
• 00850594007929: Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w
• 00850594007912: Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table stand & extendable
• 00850594007905: Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & extenda
• 00850594007899: Profile System; with ColorBurst and Mini OLED with table stand & extendable arm is a clinical an
• 00850594007882: Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand & e
• 00850594007875: Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand
• 00850594007868: Profile System; with Xenon ColorDome and Mini OLED with table stand & extendable arm is a clinic
• 00850594007851: Profile System; with Non-Xenon ColorDome and Mini OLED with table stand & extendable arm is a cl
• 00850594007844: Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with
• 00850594007837: Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w
• 00850594007820: Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clini
• 00850594007813: Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a c
• 00850594007806: Profile System; with ColorBurst and Mini OLED with extendable arm is a clinical and research vis
• 00850594007790: Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable arm
• 00850594007783: Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable
• 00850594007776: Profile System; with Xenon ColorDome and Mini OLED with extendable arm is a clinical and researc
• 00850594007769: Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand is a
• 00850594007752: E3 System; with Mini OLED and no computer is a clinical and research visual electrophysiology sy
• 00850594007745: E3 System; with Mini OLED and Desktop Computer is a clinical and research visual electrophysiolo
• 00850594007738: E3 System; with Mini OLED and Tablet Computer is a clinical and research visual electrophysiolog
• 00850594007721: E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu
• 00850594007714: E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu
• 00850594007707: E3 System; with Non-Xenon ColorDome on an OR Stand and Mini OLED with table stand is a clinical
• 00850594007691: E3 System; with Non-Xenon ColorDome on an OR Stand and ColorBurst and Mini OLED with table stand
• 00850594007684: E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst and Mini OLED
• 00850594007677: E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst is a clinical
• 00850594007660: E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor is a clinical and research vi