BT-338N ELECTRONIC CLINICAL THERMOMETER— 510(k) K894627

Name: FDA 510(k) clearance K894627
Creator: U.S. Food and Drug Administration
Published: 1989-10-23

Substantially Equivalent

Integrated Display Technology, Ltd.

FDA 510(k) clearance K894627 for BT-338N ELECTRONIC CLINICAL THERMOMETER, Substantially Equivalent on 1989-10-23. Applicant: Integrated Display Technology, Ltd.. Device class: 2.

Clearance details

Applicant: Integrated Display Technology, Ltd.
Product code: Code FCI
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1989-07-24
Decision date: 1989-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, Hong Kong, HK

Download summary PDF View on FDA.gov ↗

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