The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Acta Metra/acta Gnosis Firmware Package.
| Device ID | K900385 |
| 510k Number | K900385 |
| Device Name: | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1991-07-09 |