TRENDCARE CALIBRATOR MODEL SCU 7007— 510(k) K983198

Name: FDA 510(k) clearance K983198
Creator: U.S. Food and Drug Administration
Published: 1999-11-23

Substantially Equivalent

Diametrics Medical, Ltd.

FDA 510(k) clearance K983198 for TRENDCARE CALIBRATOR MODEL SCU 7007, Substantially Equivalent on 1999-11-23. Applicant: Diametrics Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Diametrics Medical, Ltd.
Product code: Code CCC
Device class: Class 2
Regulation: 21 CFR 868.1150
Advisory panel: Anesthesiology
Date received: 1998-09-11
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: High Wycombe, Buckinghamshire, GB

Download summary PDF View on FDA.gov ↗

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