INFANT SLEEP BEANIE
FDA 510(k) clearance K082367 · decided 2009-06-12
Clearance details
- K-number
- K082367
- Device name
- INFANT SLEEP BEANIE
- Applicant
- Life Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-08-18
- Decision date
- 2009-06-12
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- FRP
- Device class
- 1
- Regulation number
- 880.5680
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wellington, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RES-Q INFANT WEDGE AND SLING (K090284) | Cr Enterprises, LLC | 2009-06-05 |
| KOZY COMFORT INFANT POSITIONER (K062143) | Alfred E Mann Inst. For Biomedical Engineering | 2006-10-24 |
| HEAD BED (K060986) | Steven H. Warnock, M.D. | 2006-07-11 |
| ROBIN HOOD VEST (K051300) | Kamber Corporation | 2005-12-08 |
| NIGHTFORM (K041996) | Plastic Surgery Solutions, LLC | 2004-08-03 |
| KENDALL-LTP TURNER SAVE-A-LINE (K003511) | The Ludlow Company LP | 2001-01-24 |
| NEONATAL RESTRAINT AND COMFORT SYSTEMS (K943017) | K.Bowmed, Inc. | 1995-01-19 |
| THE TUCKER SLING (K932636) | Tucker Designs, Ltd. | 1994-01-26 |
| INFANT REFLUX SLING (K905630) | Pedicraft, Inc. | 1991-03-13 |
| PEDICRAFT INFANT REFLUX WEDGE (K905629) | Pedicraft, Inc. | 1991-03-13 |
| CUDDLE UP PILLOW (K882544) | Ohio Medical Instrument Co., Inc. | 1989-01-31 |
| PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS (K844176) | Premie Comfort Products | 1985-01-23 |
Recalls involving this device
No recalls on record reference this clearance.