FMS — Bed, Pediatric Open Hospital Class II
FDA product code FMS covers "Bed, Pediatric Open Hospital", a Class II medical device regulated under 21 CFR 880.5140. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMS
- Device Class
- Class II
- Regulation Number
- 880.5140
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970334 | infant advantage | NATURE'S CRADLE | April 25, 1997 |
| K963210 | vail products | VAIL 100 PEDIATRIC CRIB | November 13, 1996 |
| K960747 | infant advantage | NATURE'S CRADLE MODEL C1500 | May 22, 1996 |
| K960012 | stryker | STRYKER ADEL BASSINET | March 25, 1996 |
| K951024 | infant advantage | NATURE'S CRADLE | June 5, 1995 |
| K950059 | janco consulting services | MC INFANT CARE UNIE #PP30 | February 10, 1995 |
| K950058 | janco consulting services | MC HEALTHCARE #CH31 CHILD'S CRIB | February 10, 1995 |
| K950051 | brewer | BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B | February 10, 1995 |
| K925530 | superior healthcare group | INSTRUMENT WARMER | June 18, 1993 |
| K925949 | pedicraft | PEDICRAGT BASSINET | April 20, 1993 |
| K925817 | pedicraft | HEAD & FOOT END DROP PEDI-CRIB | April 20, 1993 |
| K921327 | infant advantage | NATURE'S CRADLE HM-10 | December 29, 1992 |
| K901763 | infant advantage | NATURE'S CRADLE(TM) | March 22, 1991 |
| K900873 | hospital supply co | PEDIATRIC HOSPITAL BED | May 18, 1990 |
| K883818 | physician engineered products | MODIFIED REFLUX REDUCER | November 21, 1988 |
| K881019 | cinventa | BABYROCKER | June 7, 1988 |
| K880838 | serv-queen | BASSINET STAND WITH DRESSING TRAY | April 29, 1988 |
| K845004 | international purchasing services | CRIB CUDDLE - INFANT BED | April 23, 1986 |
| K845003 | international purchasing services | CUDDLE CARRIER - INFANT BED | April 23, 1986 |
| K845002 | international purchasing services | CUDDLE HEART -AUDITORY/VIBRATION DEVICE | April 23, 1986 |