INSPIRON NEBULO TM 28 NEBULIZER KIT— 510(k) K790982

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K790982 for INSPIRON NEBULO TM 28 NEBULIZER KIT, Substantially Equivalent on 1979-06-27. Applicant: C.R. Bard, Inc..

Clearance details

Applicant
C.R. Bard, Inc.
Product code
Code CAF
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

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.