HEALTHPHONE(TM)— 510(k) K862668

Substantially Equivalent

Carelink

FDA 510(k) clearance K862668 for HEALTHPHONE(TM), Substantially Equivalent on 1986-12-22. Applicant: Carelink. Device class: 2.

Clearance details

Applicant
Carelink
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Anaheim, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.