DeviceClearance

K822689

Substantially Equivalent

PORTABLE MONITORING & SCREENING SPIROM.

Applicant
Boehringer Laboratories
Product code
BZK
Advisory panel
Anesthesiology
Date received
Decision date
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, through . 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.