The following data is part of a premarket notification filed by Cedars-sinai Medical Center with the FDA for Csmc Cardiac Suite.
| Device ID | K172609 |
| 510k Number | K172609 |
| Device Name: | CSMC Cardiac Suite |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Cedars-Sinai Medical Center 8700 Beverly Blvd Los Angeles, CA 90048 |
| Contact | Geoff Pollard |
| Correspondent | Geoff Pollard Cedars-Sinai Medical Center 8700 Beverly Blvd Los Angeles, CA 90048 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864687000247 | K172609 | 000 |