HEALTHPHONE TOCO MODEL— 510(k) K874631

Substantially Equivalent

Carelink

FDA 510(k) clearance K874631 for HEALTHPHONE TOCO MODEL, Substantially Equivalent on 1988-03-11. Applicant: Carelink. Device class: 2.

Clearance details

Applicant: Carelink
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 1987-11-10
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Carelink

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Data sourced from openFDA. This site is unofficial and independent of the FDA.