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MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1896
Identity
- Trade Name
- LNCS TF-I SpO2, Adult Reusable Forehead Sensor , LNCS TF-1 & Headband, 3 ft >30kg EUDAMEDMasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- LNCS SET Reusable Sensors EUDAMEDMasimoSET LNCS TF-I SpO2 Reusable Forehead Sensor FDA UDI
- Model / Reference
- 1896 EUDAMEDFDA UDI
- Description
- MasimoSET LNCS TF-I SpO2 Reusable Forehead Sensor FDA UDI
Identifiers
- Catalog Number
- 1896 FDA UDI
- Primary DI / UDI-DI
- 00843997000055 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V002G2 EUDAMED
- Direct Marketing DI
- 00843997000055 EUDAMED
- 510(k) Number
- K051212 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
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
MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Pulse oximeter probe, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- APK — Apk Technology · Class II
- 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
- Masimo Forehead Sensor Headbands — 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® M-LNCS™ DCI-Pv pediatric/slender digit SpO2 reusable sensor — MASIMO CORPORATION
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
- Masimo Corporation
Sources (2)
- FDA UDI 892654cb-eb50-46db-a456-4dacebaf2810 37 fields · synced Jul 27, 2026
- EUDAMED f254c88b-f9ed-4806-8a49-0ec860c65b5f 61 fields · synced Jul 27, 2026