INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)— 510(k) K970959

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K970959 for INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT), Substantially Equivalent on 1997-06-13. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1997-03-17
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.