Identity
- Trade Name
- O3 FDA UDI
- Generic Name
- Cerebral oximeter FDA UDI
- Device Name
- O3 Regional Oximeter, Philips FDA UDI
- Model / Reference
- 4431 FDA UDI
- Description
- O3 Regional Oximeter, Philips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997013468 FDA UDI
- 510(k) Number
- K182429 FDA UDI
- FDA Product Code
- MUD FDA UDI
- GMDN Term
- Cerebral oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
No
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
Yes
FDA UDI
Category: Cerebral oximeter
O3 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cerebral oximeter.
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- Nonin — Nonin Medical, Inc. · Class II
- Nonin — Nonin Medical, Inc. · Class II
- Nonin — Nonin Medical, Inc. · Class II
- INVOS — Covidien LP · Class II
Cleared under the same submission
K182429 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
- Masimo Corporation
Sources (1)
- FDA UDI a2ed70e9-efb0-4995-aa5c-c12de033b339 35 fields · synced Jun 8, 2026