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Phonatory Aerodynamic System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 6600WU Model 6600
Identity
- Trade Name
- PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) EUDAMEDFDA UDIPHONATORY AERODYNAMIC SYSTEM FDA UDI
- Generic Name
- Electroglottograph FDA UDISpeech assistive training device FDA UDI
- Device Name
- Phonatory Aerodynamic System (PAS) EUDAMEDv4.0 PAS WIN10 UPGRADE FDA UDIPHONATORY AERODYNAMIC SYSTEM (SOFTWARE) FDA UDI
- Model / Reference
- 6600WU EUDAMEDFDA UDI6600 EUDAMEDFDA UDI
- Description
- v4.0 PAS WIN10 UPGRADE FDA UDIPHONATORY AERODYNAMIC SYSTEM (SOFTWARE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333236565 EUDAMEDFDA UDI04961333245420 FDA UDI04961333247417 FDA UDI
- Basic UDI-DI
- 496133303660026 EUDAMED
- Direct Marketing DI
- 04961333236565 EUDAMED
- FDA Product Code
- KLX FDA UDI
- EMDN Code
- Z12149010 VOICE DISPLAYS EUDAMED
- GMDN Term
- Electroglottograph FDA UDISpeech assistive training device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1325 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroglottograph
Phonatory Aerodynamic System by PENTAX of America, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (4)
- FDA UDI 9c8e958c-b3b7-4bb2-ab7d-3db73e6f2e5c 33 fields · synced Jul 9, 2026
- FDA UDI 9bfffaa7-1205-4edc-8d2a-d6e89d079703 33 fields · synced May 29, 2026
- FDA UDI 1868fec0-f5d2-4cef-aefb-21b4fc797d60 33 fields · synced May 30, 2026
- EUDAMED 55d7aa47-0c35-4c4e-8d4d-57d085008f75 61 fields · synced Jul 9, 2026