DACOMED CYSTOMETER— 510(k) K880391

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K880391 for DACOMED CYSTOMETER, Substantially Equivalent on 1988-04-27. Applicant: Dacomed Corp.. Device class: 2.

Clearance details

Applicant: Dacomed Corp.
Product code: Code EXQ
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-29
Decision date: 1988-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.