RESPIRATORY THERAPY FLOWMETER— 510(k) K802659

Substantially Equivalent

Design & Manufacturing Consultants

FDA 510(k) clearance K802659 for RESPIRATORY THERAPY FLOWMETER, Substantially Equivalent on 1980-11-12. Applicant: Design & Manufacturing Consultants.

Clearance details

Applicant: Design & Manufacturing Consultants
Product code: Code CAX
Advisory panel: Anesthesiology
Date received: 1980-10-24
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.