K033614 is an FDA 510(k) clearance for the MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on July 29, 2004, 255 days after receiving the submission on November 17, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K033614 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2003 |
| Decision Date | July 29, 2004 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1730 |