The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Scpd 1000.
Device ID | K890394 |
510k Number | K890394 |
Device Name: | MEDRAD SCPD 1000 |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
Contact | Ruey C Dempsey |
Correspondent | Ruey C Dempsey MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-25 |
Decision Date | 1989-03-14 |