Soma Safe Enclosure
FDA 510(k) K963701 · Nova Technology Corp.
510(k) numberK963701
Submission
- Device name
- Soma Safe Enclosure
- Applicant
- Nova Technology Corp.
Bristol, CT, US - Received
- September 16, 1996
- Decision date
- January 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5100
- Specialty
- General Hospital
Other 510(k)s with product code FNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202964 | iBed Wireless with iBed MobileFNL · Traditional | Stryker Corporation | 06/18/2021SE |
| K103536 | Ibed Wireless with Ibed AwarenessFNL · Traditional | Stryker Corporation | 12/16/2010SE |
| K982783 | Vail 1000 Enclosed BedFNL · Traditional | Vail Products, Inc. | 10/05/1998SE |
| K974296 | Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedFNL · Traditional | Invacare Corp. | 01/06/1998SE |
| K974254 | Benefit B3--- SeriesFNL · Traditional | M.C. Healthcare Products, Inc. | 12/16/1997SE |
| K972115 | Volker Hospital Bed, Model K960FNL · Traditional | Volker Healthcare, Inc. | 08/29/1997SE |
| K971546 | Soma 900 Transport BedFNL · Traditional | Nova Technologies, Inc. | 07/10/1997SE |
| K963622 | Vail 2000 Enclosed BedFNL · Traditional | Vail Products, Inc. | 05/07/1997SE |
| K963589 | Vail 3000 Bed EnclosureFNL · Traditional | Vail Products, Inc. | 04/21/1997SE |
| K962942 | TotalcareFNL · Traditional | Hill-Rom, Inc. | 02/03/1997SE |
More from Hill-Rom, Inc.
Questions and answers
When was Soma Safe Enclosure cleared by the FDA?
Soma Safe Enclosure (K963701) received a 510(k) decision of Substantially Equivalent on January 24, 1997, 130 days after the submission was received.
What is the product code of K963701?
The FDA product code is FNL – Bed, Ac-Powered Adjustable Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5100.