K991627 is an FDA 510(k) clearance for the WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 17, 1999, 6 days after receiving the submission on May 11, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K991627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1999 |
| Decision Date | May 17, 1999 |
| Days to Decision | 6 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LBI — Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |