The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Miniscope Ms-3.
| Device ID | K954066 |
| 510k Number | K954066 |
| Device Name: | MINISCOPE MS-3 |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1995-10-27 |