The following data is part of a premarket notification filed by Daniel & Daniel Consulting with the FDA for Cellvizio 100 Series System And Cellvizio System With Confocal Miniprobes; Uroflex B And Cystolflex F (both Trade Marked.
| Device ID | K132389 |
| 510k Number | K132389 |
| Device Name: | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED |
| Classification | Confocal Optical Imaging |
| Applicant | DANIEL & DANIEL CONSULTING 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel DANIEL & DANIEL CONSULTING 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002472747 | K132389 | 000 |
| 00827002472730 | K132389 | 000 |