The following data is part of a premarket notification filed by Bodystat Ltd. with the FDA for Bodystat 1500mdd Body Composition Monitoring Unit.
| Device ID | K994242 |
| 510k Number | K994242 |
| Device Name: | BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT |
| Classification | Analyzer, Body Composition |
| Applicant | BODYSTAT LTD. PO BOX 50 DOUGLAS ISLE OF MAN British Isles, BR Im99 1dq |
| Contact | I. J Meeuwsen |
| Correspondent | I. 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 | 1999-12-16 |
| Decision Date | 2000-03-15 |