The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Automatic Endoscope.
| Device ID | K832458 |
| 510k Number | K832458 |
| Device Name: | AUTOMATIC ENDOSCOPE |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-26 |
| Decision Date | 1983-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333240715 | K832458 | 000 |
| 04961333240708 | K832458 | 000 |