510(k) K802900
K802900 is an FDA 510(k) premarket notification submitted by Totemite Medical Electronics for the device "HEART SENTINEL". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Totemite Medical Electronics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1981
- Date Received
- November 17, 1980
- 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