SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM— 510(k) K983648

Name: FDA 510(k) clearance K983648
Creator: U.S. Food and Drug Administration
Published: 1999-02-24

Substantially Equivalent

Perry Baromedical Services

FDA 510(k) clearance K983648 for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM, Substantially Equivalent on 1999-02-24. Applicant: Perry Baromedical Services. Device class: 2.

Clearance details

Applicant: Perry Baromedical Services
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 1998-10-16
Decision date: 1999-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riviera Beach, FL, 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.