The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Quatera 700.
| Device ID | K212241 |
| 510k Number | K212241 |
| Device Name: | QUATERA 700 |
| Classification | Unit, Phacofragmentation |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Hans-Joachim Miesner |
| Correspondent | Maria Golovina Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, CA 94568 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2022-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539104533 | K212241 | 000 |
| 04049539100177 | K212241 | 000 |
| 04049539102683 | K212241 | 000 |
| 04049539102645 | K212241 | 000 |
| 04049539100504 | K212241 | 000 |
| 04049539103871 | K212241 | 000 |
| 04049539103888 | K212241 | 000 |
| 04049539103895 | K212241 | 000 |
| 04049539103949 | K212241 | 000 |
| 04049539100757 | K212241 | 000 |
| 04049539100764 | K212241 | 000 |
| 04049539064073 | K212241 | 000 |