MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS— 510(k) K002795

Name: FDA 510(k) clearance K002795
Creator: U.S. Food and Drug Administration
Published: 2000-12-06

Substantially Equivalent

Hypertec, Inc.

FDA 510(k) clearance K002795 for MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS, Substantially Equivalent on 2000-12-06. Applicant: Hypertec, Inc.. Device class: 2.

Clearance details

Applicant: Hypertec, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2000-09-07
Decision date: 2000-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, 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.