The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Autorefractor, Subjective.
Device ID | K781014 |
510k Number | K781014 |
Device Name: | AUTOREFRACTOR, SUBJECTIVE |
Classification | Refractometer, Ophthalmic |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKO |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-16 |
Decision Date | 1978-09-07 |