VISITHERM— 510(k) K852950

Substantially Equivalent

C.D. Regelin & Associates, Inc.

FDA 510(k) clearance K852950 for VISITHERM, Substantially Equivalent on 1986-02-07. Applicant: C.D. Regelin & Associates, Inc.. Device class: 3.

Clearance details

Applicant: C.D. Regelin & Associates, Inc.
Product code: Code IYM
Device class: Class 3
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1985-07-11
Decision date: 1986-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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