REAL-TIME

GUDID 04961333229796

Real-Time EGG Analysis Software

PENTAX OF AMERICA, INC.

Electroglottograph

• Primary Device ID: 04961333229796
• NIH Device Record Key: 674fcdf0-e6cf-4191-baca-4fa84db23499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAL-TIME
• Version Model Number: 5138
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333229796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990240

FDA Product Code

• KLX: Electroglottograph

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: 2017-04-06

On-Brand Devices [REAL-TIME]

• 04961333229796: Real-Time EGG Analysis Software
• 04961333229789: Real-Time Spectrogram Software
• 04961333229765: Real-Time Pitch Software