The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Model 2240 Semi-rigid Otoscope.
| Device ID | K932259 |
| 510k Number | K932259 |
| Device Name: | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE |
| Classification | Otoscope |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-20 |
| Decision Date | 1993-12-15 |