The following data is part of a premarket notification filed by Frontline Medical with the FDA for Epistat, V-stat, Models Epistat-001-01, V-stat-001-01.
| Device ID | K060289 |
| 510k Number | K060289 |
| Device Name: | EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | FRONTLINE MEDICAL INNOVATION WORKS NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Paul Slattery |
| Correspondent | Paul Slattery FRONTLINE MEDICAL INNOVATION WORKS NATIONAL TECHNOLOGY PARK Limerick, IE |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-07-07 |
| Summary: | summary |