K022876 is an FDA 510(k) clearance for the MODIFICATION TO INFANT LIFE SUPPORT MODULE-20. This device is classified as a Incubator, Neonatal Transport (Class II - Special Controls, product code FPL).
Submitted by International Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on September 11, 2002, 12 days after receiving the submission on August 30, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5410.
| 510(k) Number | K022876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2002 |
| Decision Date | September 11, 2002 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPL — Incubator, Neonatal Transport |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5410 |