The following data is part of a premarket notification filed by Nova Technology Corp. with the FDA for Soma Safe Enclosure.
| Device ID | K963701 |
| 510k Number | K963701 |
| Device Name: | SOMA SAFE ENCLOSURE |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | NOVA TECHNOLOGY CORP. 545 MIDDLE ST. Bristol, CT 06010 |
| Contact | Stephen M Fisher, Ii |
| Correspondent | Stephen M Fisher, Ii NOVA TECHNOLOGY CORP. 545 MIDDLE ST. Bristol, CT 06010 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-01-24 |