The following data is part of a premarket notification filed by Syntermed, Inc. with the FDA for Bp-spect V1.o.
| Device ID | K042258 |
| 510k Number | K042258 |
| Device Name: | BP-SPECT V1.O |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SYNTERMED, INC. 245 OWENS DR. Anaheim, CA 92808 |
| Contact | Kenneth F Van Train |
| Correspondent | Kenneth F Van Train SYNTERMED, INC. 245 OWENS DR. Anaheim, CA 92808 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-20 |
| Decision Date | 2004-10-04 |
| Summary: | summary |