BIRD (IPV) NONCONTINUOUS VENTILATORS— 510(k) K895485

Substantially Equivalent

Percussionaire Corp.

FDA 510(k) clearance K895485 for BIRD (IPV) NONCONTINUOUS VENTILATORS, Substantially Equivalent on 1989-10-30. Applicant: Percussionaire Corp..

Clearance details

Applicant
Percussionaire Corp.
Product code
Code NHJ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sandpoint, ID, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NHJ

product code NHJ
Death
7
Total
7

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.