RESPIRADYNE II(TM)— 510(k) K863866

Substantially Equivalent

Chesebrough-Pond'S U.S.A. Co.

FDA 510(k) clearance K863866 for RESPIRADYNE II(TM), Substantially Equivalent on 1987-01-28. Applicant: Chesebrough-Pond'S U.S.A. Co..

Clearance details

Applicant: Chesebrough-Pond'S U.S.A. Co.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1986-10-03
Decision date: 1987-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trumbull, CT, US

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.