Identity
- Trade Name
- Cochlear FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Osia™ Fitting Software 2 FDA UDI
- Model / Reference
- P1593077 FDA UDI
- Description
- Osia™ Fitting Software 2 FDA UDI
Identifiers
- Catalog Number
- P1593077 FDA UDI
- Primary DI / UDI-DI
- 09321502046503 FDA UDI
- 510(k) Number
- K191921 FDA UDI
- FDA Product Code
- PFO FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3340 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Audiometric/hearing device software
Cochlear by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Widex — Widex A/S · Class I
- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- GN Hearing — Gn Hearing A/S · Class II
Cleared under the same submission
K191921 also covers:
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear™ Sterile Non-Magnetic Plug — Cochlear
- Cochlear™ Sterile Replacement Magnet — Cochlear
- Osia® 2 Aqua+ — Cochlear
- Osia® 2 Sound Processor Magnet Pack (strength 1) — Cochlear
- Osia® 2 Sound Processor Magnet Pack (strength 2) — Cochlear
- Osia® 2 Sound Processor Magnet Pack (strength 3) — Cochlear
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI 0ac63c50-86f7-474d-9e9c-0a24e8aee2c8 36 fields · synced May 30, 2026