DOWNS ADJUSTABLE FLOW GENERATOR— 510(k) K831503

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K831503 for DOWNS ADJUSTABLE FLOW GENERATOR, Substantially Equivalent on 1983-09-12. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1983-05-11
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYE

product code BYE

Death: 5
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.