The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Plex Elite 9000 Ss-oct.
| Device ID | K161194 |
| 510k Number | K161194 |
| Device Name: | PLEX Elite 9000 SS-OCT |
| Classification | Tomography, Optical Coherence |
| Applicant | CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057748087110 | K161194 | 000 |