Identity
- Trade Name
- O3 FDA UDI
- Generic Name
- Cerebral oximeter sensor, single-use FDA UDI
- Device Name
- O3 Sensor Infant/Neonatal Adhesive Sensor FDA UDI
- Model / Reference
- 4384 FDA UDI
- Description
- O3 Sensor Infant/Neonatal Adhesive Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997013496 FDA UDI
- 510(k) Number
- K182429 FDA UDI
- FDA Product Code
- MUD FDA UDI
- GMDN Term
- Cerebral oximeter sensor, single-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cerebral oximeter sensor, single-use
O3 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 aacf94d7-4a86-4b8c-ab9b-6d9401ad4520 35 fields · synced May 30, 2026