The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for At 030.
| Device ID | K180839 |
| 510k Number | K180839 |
| Device Name: | AT 030 |
| Classification | Tonometer, Manual |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Becky Ditty Biologics Consulting 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471090260 | K180839 | 000 |