510(k) K900385
K900385 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE". The FDA issued a decision of Substantially Equivalent on July 9, 1991. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1991
- Date Received
- January 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type