WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM— 510(k) K952545

Name: FDA 510(k) clearance K952545
Creator: U.S. Food and Drug Administration
Published: 1997-05-28

Substantially Equivalent

Wright Industries

FDA 510(k) clearance K952545 for WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM, Substantially Equivalent on 1997-05-28. Applicant: Wright Industries. Device class: 2.

Clearance details

Applicant: Wright Industries
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 1995-06-02
Decision date: 1997-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

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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.