K132543 is an FDA 510(k) clearance for the INFANT INCUBATOR. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Bistos Co., Ltd. (Ramsey, US). The FDA issued a Cleared decision on July 3, 2014, 324 days after receiving the submission on August 13, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K132543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2013 |
| Decision Date | July 03, 2014 |
| Days to Decision | 324 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |