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 |