Identity
- Trade Name
- Ultraview DM3 FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. FDA UDI
- Model / Reference
- 91330-M FDA UDI
- Description
- The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. FDA UDI
Identifiers
- Catalog Number
- 175-6100 FDA UDI
- Primary DI / UDI-DI
- 00851920007002 FDA UDI
- 510(k) Number
- K093802 FDA UDI
- FDA Product Code
- DQA FDA UDIDXN FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.1130 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
MR Unsafe FDA UDI
Category: Multiple vital physiological parameter monitoring system, clinical
Ultraview DM3 by Zoe Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vital physiological parameter monitoring system, clinical.
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Tempus Pro — Remote Diagnostic Technologies Limited · Class II
- Comen — Shenzhen Comen Medical Instruments Co., LTD. · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Lutech — Lutech Industries · Class II
Cleared under the same submission
K093802 also covers:
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
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
- Zoe Medical Incorporated
Sources (1)
- FDA UDI 8d640a25-a4d6-40ce-bc00-d8e4883238c0 36 fields · synced May 30, 2026