BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM— 510(k) K012323

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K012323 for BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 2001-12-20. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2001-07-23
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Murrysville, PA, US

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Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.