MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR— 510(k) K991785

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K991785 for MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR, Substantially Equivalent on 1999-08-17. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1999-05-25
Decision date: 1999-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.