The following data is part of a premarket notification filed by Bodystat Ltd. with the FDA for Quadscan 4000 Body Body Composition, Fluid & Illness/segmental Monitoring Unit.
| Device ID | K082255 |
| 510k Number | K082255 |
| Device Name: | QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT |
| Classification | Analyzer, Body Composition |
| Applicant | BODYSTAT LTD. PO BOX 50 DOUGLAS ISLE OF MAN British Isles, GB Im99 1dq |
| Contact | I J. Meeuwsen |
| Correspondent | I J. Meeuwsen BODYSTAT LTD. PO BOX 50 DOUGLAS ISLE OF MAN British Isles, GB Im99 1dq |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2011-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060502140043 | K082255 | 000 |