The following data is part of a premarket notification filed by Anzai Medical Co, Ltd. with the FDA for Ez-scope An, Ez-scope Light.
| Device ID | K022342 |
| 510k Number | K022342 |
| Device Name: | EZ-SCOPE AN, EZ-SCOPE LIGHT |
| Classification | Camera, Scintillation (gamma) |
| Applicant | ANZAI MEDICAL CO, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 -2233 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ANZAI MEDICAL CO, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 -2233 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-10-09 |
| Summary: | summary |