ATA HCM MONOPLACE HYPERBARIC SYSTEM— 510(k) K040145

Substantially Equivalent

Ata Hyperbaric Chamber Manufacturing

FDA 510(k) clearance K040145 for ATA HCM MONOPLACE HYPERBARIC SYSTEM, Substantially Equivalent on 2005-05-04. Applicant: Ata Hyperbaric Chamber Manufacturing.

Clearance details

Applicant: Ata Hyperbaric Chamber Manufacturing
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2004-01-22
Decision date: 2005-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, Bc, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.