The following data is part of a premarket notification filed by Strichman Medical Equipment, Inc. with the FDA for Equilibrium Radionuclide Angiocardioraphy Analysis.
| Device ID | K925186 |
| 510k Number | K925186 |
| Device Name: | EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | STRICHMAN MEDICAL EQUIPMENT, INC. 93 WEST TECH CENTER Medfield, MA 02052 |
| Contact | Paul Franzosa |
| Correspondent | Paul Franzosa STRICHMAN MEDICAL EQUIPMENT, INC. 93 WEST TECH CENTER Medfield, MA 02052 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1993-01-12 |