The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Invisio Icn, Models Icn-0564 And Icn-0565.
| Device ID | K042225 |
| 510k Number | K042225 |
| Device Name: | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925027497 | K042225 | 000 |
| 00821925027480 | K042225 | 000 |