OXYGEN TREATMENT HOOD— 510(k) K011592

Substantially Equivalent

Amron International Diving Supply, Inc.

FDA 510(k) clearance K011592 for OXYGEN TREATMENT HOOD, Substantially Equivalent on 2002-06-19. Applicant: Amron International Diving Supply, Inc..

Clearance details

Applicant
Amron International Diving Supply, Inc.
Product code
Code CBF
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Escondido, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CBF

product code CBF
Death
6
Total
6

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.