The following data is part of a premarket notification filed by Medic, Inc. with the FDA for Model 900ge1500 Head/neck Coil.
Device ID | K940874 |
510k Number | K940874 |
Device Name: | MODEL 900GE1500 HEAD/NECK COIL |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MEDIC, INC. P.O. BOX 737 925 WEST 6TH STREET Fremont, NE 68025 |
Contact | Randall W Jones |
Correspondent | Randall W Jones MEDIC, INC. P.O. BOX 737 925 WEST 6TH STREET 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 | 1994-02-25 |
Decision Date | 1994-06-03 |