The following data is part of a premarket notification filed by Micromedical, Inc. with the FDA for Cardioview Transtelephonic Software.
| Device ID | K955891 |
| 510k Number | K955891 |
| Device Name: | CARDIOVIEW TRANSTELEPHONIC SOFTWARE |
| Classification | Electrocardiograph |
| Applicant | MICROMEDICAL, INC. 1151 HOPE ST. Stanford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen MICROMEDICAL, INC. 1151 HOPE ST. Stanford, CT 06907 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-29 |
| Decision Date | 1996-10-08 |
| Summary: | summary |