The following data is part of a premarket notification filed by Bodystat Ltd. with the FDA for Bodystay.
| Device ID | K951097 |
| 510k Number | K951097 |
| Device Name: | BODYSTAY |
| Classification | Plethysmograph, Impedance |
| 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 | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-11-22 |