510(k) K895806
K895806 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "ELATEC HOLTER ANALYZER". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1990
- Date Received
- September 28, 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