DOWNS VPAP CIRCUIT— 510(k) K852333

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K852333 for DOWNS VPAP CIRCUIT, Substantially Equivalent on 1985-10-16. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1985-05-31
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

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Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.