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 | Apr 25, 1997 |
| K963210 | Vail Products | VAIL 100 PEDIATRIC CRIB | Nov 13, 1996 |
| K960747 | Infant Advantage | NATURE'S CRADLE MODEL C1500 | May 22, 1996 |
| K960012 | Stryker | STRYKER ADEL BASSINET | Mar 25, 1996 |
| K951024 | Infant Advantage | NATURE'S CRADLE | Jun 5, 1995 |
| K950051 | Brewer | BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B | Feb 10, 1995 |
| K950058 | Janco Consulting Services | MC HEALTHCARE #CH31 CHILD'S CRIB | Feb 10, 1995 |
| K950059 | Janco Consulting Services | MC INFANT CARE UNIE #PP30 | Feb 10, 1995 |
| K925530 | Superior Healthcare Group | INSTRUMENT WARMER | Jun 18, 1993 |
| K925949 | Pedicraft | PEDICRAGT BASSINET | Apr 20, 1993 |
| K925817 | Pedicraft | HEAD & FOOT END DROP PEDI-CRIB | Apr 20, 1993 |
| K921327 | Infant Advantage | NATURE'S CRADLE HM-10 | Dec 29, 1992 |
| K901763 | Infant Advantage | NATURE'S CRADLE(TM) | Mar 22, 1991 |
| K900873 | Hospital Supply Co | PEDIATRIC HOSPITAL BED | May 18, 1990 |
| K883818 | Physician Engineered Products | MODIFIED REFLUX REDUCER | Nov 21, 1988 |
| K881019 | Cinventa | BABYROCKER | Jun 7, 1988 |
| K880838 | Serv-Queen | BASSINET STAND WITH DRESSING TRAY | Apr 29, 1988 |
| K845002 | International Purchasing Services | CUDDLE HEART -AUDITORY/VIBRATION DEVICE | Apr 23, 1986 |
| K845003 | International Purchasing Services | CUDDLE CARRIER - INFANT BED | Apr 23, 1986 |
| K845004 | International Purchasing Services | CRIB CUDDLE - INFANT BED | Apr 23, 1986 |