510(k) K922027
K922027 is an FDA 510(k) premarket notification submitted by Biosensor Corp. for the device "AMBULATORY (HOLTER) RECORDING, MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 17, 1993. 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
- February 17, 1993
- Date Received
- March 26, 1992
- 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