The following data is part of a premarket notification filed by Bodystat Ltd. with the FDA for Bodystat Dualscan 2005.
| Device ID | K980971 |
| 510k Number | K980971 |
| Device Name: | BODYSTAT DUALSCAN 2005 |
| 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 | 1998-03-16 |
| Decision Date | 1998-06-11 |