Identity
- Trade Name
- Handheld Pulse Monitor FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2), and pulse rate of patient. FDA UDI
- Model / Reference
- M800 FDA UDI
- Description
- The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2), and pulse rate of patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932562310058 FDA UDI
- 510(k) Number
- K101694 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Pulse oximeter
Handheld Pulse Monitor by Guangdong Biolight Meditech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
- Nonin — Nonin Medical, Inc. · Class II
- acurio — XIAMEN ACURIO INSTRUMENT CO., LTD · Class II
- MightySat — MASIMO CORPORATION · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Andesfit — ANDESFIT LIMITED · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
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
- Guangdong Biolight Meditech Co., Ltd.
Sources (1)
- FDA UDI 6d85a21b-2d55-446b-8dc4-12f792d8ab17 34 fields · synced May 31, 2026