Identifiers
- 510(k) Number
- K002835 FDA 510(k)
- FDA Product Code
- MNW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bodystat is an analyzer for body composition. It is classified as a Class II medical device under the cardiovascular specialty.
The device received FDA 510(k) clearance (K002835) on July 3, 2001, as substantially equivalent to a predicate device. It is manufactured by Bodystat, Ltd., located in Douglas, Isle of Man, British Isles.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002835 | Class II | Active |
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Manufacturer
- Manufacturer
- Bodystat , Ltd.
Sources (1)
- FDA 510(k) K002835 24 fields · synced Sep 26, 2026