Identity
- Trade Name
- Masimo Forehead Sensor Headbands FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Model / Reference
- 3929 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997009154 FDA UDI
- 510(k) Number
- K051212 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, reusable
Masimo Forehead Sensor Headbands by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, reusable.
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- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K051212 also covers:
- LNCS SpO2 — MASIMO CORPORATION
- LNCS® DCI® Reusable Starter Kit — MASIMO CORPORATION
- M-LNCS DCI SpO2 Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- M-LNCS™ DCI-P SpO2 Pediatric/Slender digit Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- MasimoSET LNCS® DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor — MASIMO CORPORATION
- MasimoSET LNCS® DCI® SpO2 Adult Reusable Finger Clip Sensor — MASIMO CORPORATION
- MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor — MASIMO CORPORATION
- MasimoSET LNCS® YI SpO2 Multisite Reusable Sensor — MASIMO CORPORATION
- MasimoSET® LNCS® DCI-Pv pediatric/slender digit SpO2 reusable sensor — MASIMO CORPORATION
- MasimoSET® LNCS® DCIv adult SpO2 Reusable Sensor — MASIMO CORPORATION
- MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor — MASIMO CORPORATION
- MasimoSET® M-LNCS™ DCI-Pv pediatric/slender digit SpO2 reusable sensor — MASIMO CORPORATION
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 9679797a-5b20-4b02-8865-71962075662d 34 fields · synced Jun 8, 2026