The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Corvis St.
| Device ID | K113066 |
| 510k Number | K113066 |
| Device Name: | CORVIS ST |
| Classification | Tonometer, Ac-powered |
| Applicant | OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar, DE D-35582 |
| Contact | Eckhard Loh |
| Correspondent | Eckhard Loh OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar, DE D-35582 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-17 |
| Decision Date | 2012-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049584014085 | K113066 | 000 |