Identity
- Trade Name
- Solar GI air-charged 4P, Compact Pole system FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- Solar GI air-charged 4P, Compact Pole system, 115V FDA UDI
- Model / Reference
- G3-7 Air FDA UDI
- Description
- Solar GI air-charged 4P, Compact Pole system, 115V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720648846007 FDA UDI
- 510(k) Number
- K121014 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Manometric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 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: Manometric gastrointestinal motility analysis system
Solar GI air-charged 4P, Compact Pole system by Medical Measurement Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121014 also covers:
- Solar GI HRAM H2O, 24p, Trolley system — Medical Measurement Systems B.V.
- Solar GI HRAM H2O, 24p, Trolley system — Medical Measurement Systems B.V.
- Solar GI HRM H20, 24p, Compact Pole system — Medical Measurement Systems B.V.
- Solar GI HRM H20, 24p, Trolley system — Medical Measurement Systems B.V.
- Solar GI HRM H2O, 36p, Trolley system — Medical Measurement Systems B.V.
- Solar GI LGI H20, Trolley system — Medical Measurement Systems B.V.
- Solar GI UGI H20, Trolley system — Medical Measurement Systems B.V.
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 Measurement Systems B.V.
Sources (1)
- FDA UDI 6a6f9e0b-96d9-42da-9e72-346625d0a2e8 34 fields · synced May 30, 2026