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 |