510(k) K862668
K862668 is an FDA 510(k) premarket notification submitted by Carelink for the device "HEALTHPHONE(TM)". The FDA issued a decision of Substantially Equivalent on December 22, 1986. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Carelink has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1986
- Date Received
- July 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type