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 |