BREAS PV 10I CPAP SYSTEM, MODEL PV 10I— 510(k) K030985

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K030985 for BREAS PV 10I CPAP SYSTEM, MODEL PV 10I, Substantially Equivalent on 2003-10-15. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2003-03-28
Decision date: 2003-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.