The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Ott Disinfector For Flexible Endoscopes.
| Device ID | K862402 |
| 510k Number | K862402 |
| Device Name: | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | MEDIVATORS, INC. 2550 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Contact | James W Moen |
| Correspondent | James W Moen MEDIVATORS, INC. 2550 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1987-02-03 |