Product code FMS
- Device name
- Bed, Pediatric Open Hospital
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5140
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970334 | NATURE'S CRADLE | Infant Advantage, Inc. | 1997-04-25 |
| K963210 | VAIL 100 PEDIATRIC CRIB | Vail Products, Inc. | 1996-11-13 |
| K960747 | NATURE'S CRADLE MODEL C1500 | Infant Advantage, Inc. | 1996-05-22 |
| K960012 | STRYKER ADEL BASSINET | Stryker Corp. | 1996-03-25 |
| K951024 | NATURE'S CRADLE | Infant Advantage, Inc. | 1995-06-05 |
| K950059 | MC INFANT CARE UNIE #PP30 | Janco Consulting Services | 1995-02-10 |
| K950058 | MC HEALTHCARE #CH31 CHILD'S CRIB | Janco Consulting Services | 1995-02-10 |
| K950051 | BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B | The Brewer Co. | 1995-02-10 |
| K925530 | INSTRUMENT WARMER | Superior Healthcare Group, Inc. | 1993-06-18 |
| K925949 | PEDICRAGT BASSINET | Pedicraft, Inc. | 1993-04-20 |
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | Pedicraft, Inc. | 1993-04-20 |
| K921327 | NATURE'S CRADLE HM-10 | Infant Advantage, Inc. | 1992-12-29 |
| K901763 | NATURE'S CRADLE(TM) | Infant Advantage, Inc. | 1991-03-22 |
| K900873 | PEDIATRIC HOSPITAL BED | Hospital Supply Co., Inc. | 1990-05-18 |
| K883818 | MODIFIED REFLUX REDUCER | Physician Engineered Products, Inc. | 1988-11-21 |
| K881019 | BABYROCKER | Cinventa AB | 1988-06-07 |
| K880838 | BASSINET STAND WITH DRESSING TRAY | Serv-Queen, Inc. | 1988-04-29 |
| K845004 | CRIB CUDDLE - INFANT BED | International Purchasing Services | 1986-04-23 |
| K845003 | CUDDLE CARRIER - INFANT BED | International Purchasing Services | 1986-04-23 |
| K845002 | CUDDLE HEART -AUDITORY/VIBRATION DEVICE | International Purchasing Services | 1986-04-23 |
| K860596 | SWEET DREEMS SIMULATOR | Sweet Dreams, Inc. | 1986-03-06 |
| K860120 | NURSERY AMBIENT LIGHT METER | Rocky Mountain Medical Corp. | 1986-02-19 |
| K853355 | N.K. PEDIATRIC CRIBS | N.K. Medical Products, Inc. | 1985-09-20 |
| K852422 | MODEL 500 PEDIATRIC STRETCHER/CRIB | Midmark Corp. | 1985-07-05 |
| K852173 | MERIVAARA CRIB TROLLEY-MODEL 381 | Daun International, Inc. | 1985-06-17 |
| K821773 | PEDICRAFT BED, MODEL B2944 | Pedicraft, Inc. | 1982-06-23 |
| K810728 | TAB PEDIATRIC CRIB | Cambridge Scientific | 1981-04-03 |
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| 08592654433973 | Tom 2 | L I N E T spol. s r.o. | 2024-02-23 |
| 00850022426773 | C1983CG | NOVUM MEDICAL PRODUCTS INC | 2024-02-14 |
| 00850022426766 | C2080FWCR | NOVUM MEDICAL PRODUCTS INC | 2024-01-12 |
| 08592654351956 | Tom 2 | L I N E T spol. s r.o. | 2023-12-11 |
| 08592654389690 | Tom 2 | L I N E T spol. s r.o. | 2023-04-14 |
| 00850022426650 | C2083CG | NOVUM MEDICAL PRODUCTS INC | 2023-02-16 |
| 00850022426643 | C2072CL | NOVUM MEDICAL PRODUCTS INC | 2022-11-17 |
| 08592654376386 | Tom 2 | L I N E T spol. s r.o. | 2022-11-16 |
| 00850022426636 | C1981CGT | NOVUM MEDICAL PRODUCTS INC | 2022-11-15 |
| 08592654289884 | Tom 2 | L I N E T spol. s r.o. | 2022-04-29 |
| 08592654353882 | Tom 2 | L I N E T spol. s r.o. | 2022-04-29 |
| 08592654348000 | Tom 2 | L I N E T spol. s r.o. | 2022-02-28 |
| 08592654345450 | Tom 2 | L I N E T spol. s r.o. | 2022-01-21 |
| 00850925007802 | E2072CLT | NOVUM MEDICAL PRODUCTS INC | 2020-05-27 |
| 00850925007789 | E1982CG-CH | NOVUM MEDICAL PRODUCTS INC | 2020-03-25 |
| B751PDLFT0 | PediaLift | PEDIALIFT LLC | 2019-05-07 |
| 08592654184066 | Tom 2 | L I N E T spol. s r.o. | 2018-07-30 |
| 08592654145159 | Tom 2 | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654145142 | Tom 2 | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654137550 | Tom 2 | L I N E T spol. s r.o. | 2018-04-04 |
| 08592654145128 | Tom 2 | L I N E T spol. s r.o. | 2017-07-26 |
| 08592654145135 | Tom 2 | L I N E T spol. s r.o. | 2017-07-26 |
| 00852231007781 | H1975 Homecare Springfield Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007767 | H1955 Homecare Springfield Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007743 | H1943 Homecare Springfield Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007736 | H1982 HomeCare Standard Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007729 | H1973 HomeCare Standard Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007705 | H1952 HomeCare Standard Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |
| 00852231007682 | H1942 HomeCare Standard Crib | HARD MANUFACTURING CO., INC. | 2017-02-20 |