The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Conphar Otoscope/opthalmascope.
Device ID | K813299 |
510k Number | K813299 |
Device Name: | CONPHAR OTOSCOPE/OPTHALMASCOPE |
Classification | Otoscope |
Applicant | CONPHAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ERA |
CFR Regulation Number | 874.4770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-23 |
Decision Date | 1982-01-19 |