K983642 is an FDA 510(k) clearance for the COOK MINI-INCUBATOR, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 1, 1999, 108 days after receiving the submission on October 16, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K983642 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 1998 |
| Decision Date | February 01, 1999 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG — Accessory, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6120 |