SPIROMETER ISOLATION VALVE #8890— 510(k) K833088

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K833088 for SPIROMETER ISOLATION VALVE #8890, Substantially Equivalent on 1983-10-28. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1983-09-12
Decision date: 1983-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.