The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Personal C3 3-channel Electrocardiograph.
| Device ID | K851322 |
| 510k Number | K851322 |
| Device Name: | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Contact | Julian P Kaye |
| Correspondent | Julian P Kaye PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-02 |
| Decision Date | 1985-05-16 |