Identity
- Trade Name
- ELECTROGLOTTOGRAPH FDA UDI
- Generic Name
- Electroglottograph FDA UDI
- Device Name
- KayPentax Electroglottograph FDA UDI
- Model / Reference
- 6103 FDA UDI
- Description
- KayPentax Electroglottograph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333229888 FDA UDI
- 510(k) Number
- K990240 FDA UDI
- FDA Product Code
- KLX FDA UDI
- GMDN Term
- Electroglottograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1325 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroglottograph
Electroglottograph by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroglottograph.
- Two Channel Electroglottograph EG2-PCX2 — Glottal Enterprises, Inc. · Class II
- PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
- ADSV — PENTAX of America, Inc. · Class II
- SONA-SPEECH II — PENTAX of America, Inc. · Class II
- NASOMETER II — PENTAX of America, Inc. · Class II
- REAL-TIME — PENTAX of America, Inc. · Class II
- PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
- NASOMETER II — PENTAX of America, Inc. · Class II
Cleared under the same submission
K990240 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 808d5a9b-8904-4534-b3fd-5e1bfa407bea 35 fields · synced May 30, 2026