K884086 is an FDA 510(k) clearance for the C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR. This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on November 14, 1988, 48 days after receiving the submission on September 27, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K884086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1988 |
| Decision Date | November 14, 1988 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |