The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Personal Cl Single-channel Electrocar.
| Device ID | K842123 |
| 510k Number | K842123 |
| Device Name: | PERSONAL CL SINGLE-CHANNEL ELECTROCAR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Contact | Anne B Sayigh |
| Correspondent | Anne B Sayigh PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-29 |
| Decision Date | 1984-11-16 |