The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Cardiac Spect Pallet.
Device ID | K912286 |
510k Number | K912286 |
Device Name: | CARDIAC SPECT PALLET |
Classification | Bed, Scanning, Nuclear |
Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Contact | Irena M Krutulis |
Correspondent | Irena M Krutulis SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
Product Code | IYZ |
CFR Regulation Number | 892.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-23 |
Decision Date | 1991-08-02 |