510(k) K895266
K895266 is an FDA 510(k) premarket notification submitted by Biosensor Corp. for the device "AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Biosensor Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1990
- Date Received
- August 23, 1989
- 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