PORTABLE MONITORING & SCREENING SPIROM.— 510(k) K822689

Substantially Equivalent

Boehringer Laboratories

FDA 510(k) clearance K822689 for PORTABLE MONITORING & SCREENING SPIROM., Substantially Equivalent on 1983-07-12. Applicant: Boehringer Laboratories.

Clearance details

Applicant: Boehringer Laboratories
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1982-09-03
Decision date: 1983-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.