K912908 is an FDA 510(k) clearance for the AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on December 13, 1991, 164 days after receiving the submission on July 2, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K912908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1991 |
| Decision Date | December 13, 1991 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LBI — Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |