FDA.reportPublic FDA data

SEP 2 Channel Fiber Optic Cable (Power)

Primary DI
00817020020198
Brand
SEP 2 Channel Fiber Optic Cable (Power)
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M013200S
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052060000OPTI-AMP DC-POWEREDIntelligent Hearing Systems2005-08-31GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020198008170200201988170200201980817020020198

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154870455
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00817020020990Trigger Out Cable for USB Jr DuetM0131532026-06-10
00817020021027Toy Cabinet (Small)M025400S2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)M0111142026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandM0150562026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandM0150572026-06-10
00817020021119Reusable Safety Snap Leads 40" (3) for Duet/Aria/SoloM013933S2026-06-10
00817020021133OAE Probe OP23M0322002026-06-10
00817020021140Diagnostic CartM998920D2026-06-10
00817020021218DD450 HF HeadphonesM0150602026-06-10
00817020021225DD45S (10 Ohms) HeadphonesM0150802026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandM0150812026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandM0150822026-06-10
00817020020280Capella2 OAE Start-Up Kit8-69-428002026-06-09
00817020021003B81 Bone VibratorM0144022026-06-09
00817020021010B81 Bone Vibrator CableM0144032026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaM0144052026-06-09
00817020021171Bone Vibrator Cable for AriaM0144062026-06-09
00817020020044Lilly TM-Wick Electrode CableM0139142016-09-24
00817020020068eABR Cable for USB Jr DuetM0131522016-09-24

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