Identity
- Trade Name
- Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Model 1307 3 CH ULTRA Recorder FDA UDI
- Model / Reference
- Model 1307 Kit FDA UDI
- Description
- Model 1307 3 CH ULTRA Recorder FDA UDI
Identifiers
- Catalog Number
- A10-1307-00 FDA UDI
- Primary DI / UDI-DI
- 00817980020443 FDA UDI
- 510(k) Number
- K111180 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic ambulatory recorder
Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111180 also covers:
- 12-Ch ECG Holter Patient Cable w/10 Leads — VASOMEDICAL, INC.
- 2GB SD Memory Card — VASOMEDICAL, INC.
- 3-Ch ECG Holter Patient Cable w/5 Leads — VASOMEDICAL, INC.
- 3-Ch ECG Holter Patient Cable w/7 Leads — VASOMEDICAL, INC.
- Adult BP Cuff (large) 32-42cm — VASOMEDICAL, INC.
- Adult BP Cuff (standard) 24-32cm — VASOMEDICAL, INC.
- Infared Communication Adaptor — VASOMEDICAL, INC.
- Pediatric BP Cuff (small/child) 17-25cm — VASOMEDICAL, INC.
- Portable Case w/Belt for 1303 Recorder — VASOMEDICAL, INC.
- Portable case with Belt for 1304/1305 Recorder — VASOMEDICAL, INC.
- Portable case with Belt for 1805 Monitor — VASOMEDICAL, INC.
- Portable case with Belt for 2301/2302 Recorders — VASOMEDICAL, 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
- Vasomedical, Inc.
Sources (1)
- FDA UDI 8094ec84-a699-4353-84ea-08e1dd4c49ad 37 fields · synced Jun 1, 2026