The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Magnetic Resonance Diagnostic System.
Device ID | K962061 |
510k Number | K962061 |
Device Name: | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-28 |
Decision Date | 1996-11-27 |
Summary: | summary |