HYDRA METER— 510(k) K974127

Substantially Equivalent

Automata Instrumentation, Inc.

FDA 510(k) clearance K974127 for HYDRA METER, Substantially Equivalent on 1997-12-19. Applicant: Automata Instrumentation, Inc..

Clearance details

Applicant: Automata Instrumentation, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-03
Decision date: 1997-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.