DOWNS VPAP CIRCUIT— 510(k) K852333

Name: FDA 510(k) clearance K852333
Creator: U.S. Food and Drug Administration
Published: 1985-10-16

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K852333 for DOWNS VPAP CIRCUIT, Substantially Equivalent on 1985-10-16. Applicant: Vital Signs, Inc.. Device class: 1.

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1985-05-31
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

Download summary PDF View on FDA.gov ↗

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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.