The following data is part of a premarket notification filed by Medic, Inc. with the FDA for Model #510ge1500 Liver Array Coil.
Device ID | K933297 |
510k Number | K933297 |
Device Name: | MODEL #510GE1500 LIVER ARRAY COIL |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MEDIC, INC. 925 WEST 6TH ST. P.O. BOX 737 Fremont, NE 68025 |
Contact | Randall W Jones |
Correspondent | Randall W Jones MEDIC, INC. 925 WEST 6TH ST. P.O. BOX 737 Fremont, NE 68025 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-07 |
Decision Date | 1993-11-02 |