AMBULATORY PH DATA RECORDER SYSTEM, APH-2000— 510(k) K882551

Name: FDA 510(k) clearance K882551
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

Intl. Biomedics, Inc.

FDA 510(k) clearance K882551 for AMBULATORY PH DATA RECORDER SYSTEM, APH-2000, Substantially Equivalent on 1988-10-12. Applicant: Intl. Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Biomedics, Inc.
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1988-06-21
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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