Carecube Negative Pressure Isolation Chamber— 510(k) K231256

Name: FDA 510(k) clearance K231256
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Substantially Equivalent

Carecubes, Inc.

FDA 510(k) clearance K231256 for Carecube Negative Pressure Isolation Chamber, Substantially Equivalent on 2024-01-03. Applicant: Carecubes, Inc.. Device class: 2.

Clearance details

Applicant: Carecubes, Inc.
Product code: Code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 2023-05-01
Decision date: 2024-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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