The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Acta Genos Electrocardiograph.
| Device ID | K884800 |
| 510k Number | K884800 |
| Device Name: | ACTA GENOS ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge, MS 02140 |
| Contact | Sayigh, Phd |
| Correspondent | Sayigh, Phd PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge, MS 02140 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-16 |
| Decision Date | 1989-06-22 |