COUGHASSIST T70 DEVICE— 510(k) K121955

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K121955 for COUGHASSIST T70 DEVICE, Substantially Equivalent on 2012-12-14. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code NHJ
Advisory panel: Anesthesiology
Date received: 2012-07-03
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

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Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.