The following data is part of a premarket notification filed by Daum Gmbh with the FDA for Targogrid.
Device ID | K970037 |
510k Number | K970037 |
Device Name: | TARGOGRID |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | DAUM GMBH HAGENOWER STRASSE 73 Schwerin, DE 19061 |
Contact | E.j. Smith |
Correspondent | E.j. Smith DAUM GMBH HAGENOWER STRASSE 73 Schwerin, DE 19061 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-06 |
Decision Date | 1997-03-12 |