The following data is part of a premarket notification filed by Bodystat Ltd. with the FDA for Bodystat.
| Device ID | K971554 |
| 510k Number | K971554 |
| Device Name: | BODYSTAT |
| Classification | Analyzer, Body Composition |
| Applicant | BODYSTAT LTD. PO BOX 50 DOUGLAS ISLE OF MAN British Isles, BR Im99 1dq |
| Contact | L.j. Meeuwsen |
| Correspondent | L.j. Meeuwsen BODYSTAT LTD. PO BOX 50 DOUGLAS ISLE OF MAN British Isles, BR 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 | 1997-04-30 |
| Decision Date | 1997-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060502140050 | K971554 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BODYSTAT 74267832 1817767 Live/Registered |
BODYSTAT LIMITED 1992-04-21 |