The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Ecn Electronic Video Cystonephroscope.
| Device ID | K030960 |
| 510k Number | K030960 |
| Device Name: | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | John Delucia |
| Correspondent | John Delucia ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FAJ |
| Subsequent Product Code | FGA |
| Subsequent Product Code | FWF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-27 |
| Decision Date | 2003-07-16 |
| Summary: | summary |