ONE-LUNG CPAP DEVICE— 510(k) K901728

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K901728 for ONE-LUNG CPAP DEVICE, Substantially Equivalent on 1990-08-14. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1990-04-16
Decision date: 1990-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, 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.