RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD— 510(k) K062019

Substantially Equivalent

Innomed Technologies, Inc./Respcare, Inc.

FDA 510(k) clearance K062019 for RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD, Substantially Equivalent on 2006-08-17. Applicant: Innomed Technologies, Inc./Respcare, Inc..

Clearance details

Applicant: Innomed Technologies, Inc./Respcare, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2006-07-17
Decision date: 2006-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coconut Creek, FL, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.