PM-100 THERMOGRAPH MARK 1026— 510(k) K863818

Name: FDA 510(k) clearance K863818
Creator: U.S. Food and Drug Administration
Published: 1987-04-03

Substantially Equivalent

Clearwater Computer Center, Inc.

FDA 510(k) clearance K863818 for PM-100 THERMOGRAPH MARK 1026, Substantially Equivalent on 1987-04-03. Applicant: Clearwater Computer Center, Inc.. Device class: 1.

Clearance details

Applicant: Clearwater Computer Center, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1986-09-30
Decision date: 1987-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.