Identity
- Trade Name
- Orbit K FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Model / Reference
- 98-0062-03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840935100973 FDA UDI
- 510(k) Number
- K122401 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Orbit K by Suntech Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122401 also covers:
- 8 Pin Mini-Din to RS232 Cable, RoHS — SUNTECH MEDICAL, INC.
- 8 pin mini din Splitter Cable — SUNTECH MEDICAL, INC.
- Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation — SUNTECH MEDICAL, INC.
- BNC to RS232 ECG trigger cable, RoHS — SUNTECH MEDICAL, INC.
- BNC to Stereo ECG trigger cable, ROHS — SUNTECH MEDICAL, INC.
- Cable, RS232, Schiller, RoHS — SUNTECH MEDICAL, INC.
- MD — SUNTECH MEDICAL, INC.
- MD — SUNTECH MEDICAL, INC.
- Microphone Pads, Bag of 50 — SUNTECH MEDICAL, INC.
- Nonin — SUNTECH MEDICAL, INC.
- Orbit K — SUNTECH MEDICAL, INC.
- Orbit K — SUNTECH MEDICAL, 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 |
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Manufacturer
- Manufacturer
- Suntech Medical, Inc.
Sources (1)
- FDA UDI 3a047636-55f4-471a-a5a5-bfc58c298ad4 35 fields · synced Jun 6, 2026