Identity
- Trade Name
- ApexPro FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- 600MHZ TELEMETRY RECEIVER 3ED ATO FDA UDI
- Model / Reference
- 600 MHz Receiver FDA UDI
- Description
- 600MHZ TELEMETRY RECEIVER 3ED ATO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682108799 FDA UDI
- 510(k) Number
- K080251 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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: General-purpose multi-parameter bedside monitor
ApexPro by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080251 also covers:
- ApexPro — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- ApexPro — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- CARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- CARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- CARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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
- Ge Medical Systems Information Technologies, Inc.
Sources (1)
- FDA UDI bf7b196e-c165-43ba-9a72-944a95999936 36 fields · synced Jun 8, 2026