SPIROMETER, MONITORING W/ALARM— 510(k) K780064

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K780064 for SPIROMETER, MONITORING W/ALARM, Substantially Equivalent on 1978-01-31. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1978-01-12
Decision date: 1978-01-31
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.