The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Microvit Mt-100.
Device ID | K973735 |
510k Number | K973735 |
Device Name: | MICROVIT MT-100 |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780 |
Contact | Markus Maritz |
Correspondent | Markus Maritz SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-30 |
Decision Date | 1998-08-25 |
Summary: | summary |