K060289 is an FDA 510(k) clearance for the EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Frontline Medical (Limerick, IE). The FDA issued a Cleared decision on July 7, 2006, 151 days after receiving the submission on February 6, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K060289 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2006 |
| Decision Date | July 07, 2006 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |