Identity
- Trade Name
- MTS FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities. FDA UDI
- Model / Reference
- OX-610A FDA UDI
- Description
- The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities. FDA UDI
Identifiers
- Catalog Number
- OX610A FDA UDI
- Primary DI / UDI-DI
- 00869667000408 FDA UDI
- 510(k) Number
- K063641 FDA UDI
- FDA Product Code
- OCH 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
Yes
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
No
FDA UDI
Category: Pulse oximeter
Mts by Medical Test Supply — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063641 also covers:
- JOHN BUNN — GF Health Products, Inc
- JOHN BUNN — GF Health Products, Inc
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- Pulse Oximeter — Shenzhen Creative Industry Co., Ltd.
- Pulse Oximeter — Shenzhen Creative Industry Co., Ltd.
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
- Medical Test Supply
Sources (1)
- FDA UDI 0b0f5eed-eebd-40b8-8c71-bbc3c2c1220b 36 fields · synced May 30, 2026