Identity
- Trade Name
- Ultraview SL FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- OPTION,NELLCOR OXIMAX SPO2 FDA UDI
- Model / Reference
- Ultraview SL® FDA UDI
- Description
- OPTION,NELLCOR OXIMAX SPO2 FDA UDI
Identifiers
- Catalog Number
- 91496-N FDA UDI
- Primary DI / UDI-DI
- 10841522106422 FDA UDI
- 510(k) Number
- K103142 FDA UDI
- FDA Product Code
- DXN FDA UDIDSK FDA UDIDXG FDA UDIDQA FDA UDIDSI FDA UDIFLL FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI870.1110 FDA UDI870.1435 FDA UDI870.2700 FDA UDI870.1025 FDA UDI880.2910 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, multifunction
Ultraview SL by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, multifunction.
- Avalon Patient Module — Philips Medizin Systeme Böblingen GmbH · Class II
- Vital Signs Patient Monitor — Dynarex Corp. · Class II
- Avalon TOCO+ Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- MPM Module (with MR ECG, NIBP, Temp) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- SOMNOscreen plus PSG+ Tele Camera Compact AASM Set — Somnomedics GmbH
- IBP_CO_SidestreamCO2 module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Benelink module package(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- EarlySense® Chair Sensor — Earlysense, Ltd. · Class II
Cleared under the same submission
K103142 also covers:
- TruLink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
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
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 7ef6f1f5-738e-4c32-8c1d-3315199acd11 36 fields · synced Jun 8, 2026