PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251— 510(k) K014102

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K014102 for PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251, Substantially Equivalent on 2002-02-21. Applicant: Atos Medical AB.

Clearance details

Applicant: Atos Medical AB
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2001-12-13
Decision date: 2002-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Horby, SE

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.