510(k) clearances

Carecube Negative Pressure Isolation Chamber (1BY)

Carecubes, Inc. · General Hospital

K260180Substantially EquivalentTraditionalLGM
Open FDA's page for this record
Third party flag
N
City
San Francisco
Advisory committee description
General Hospital
Address 1
3101 20th St.
Statement or summary
Summary
Product code
LGM
Zip code
94110
Applicant
Carecubes, Inc.
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
Carecube Negative Pressure Isolation Chamber (1BY)
Advisory committee
HO
Contact
Steve Bollinger
K number
K260180
State
CA
Date received
2026-01-21
Review advisory committee
HO
Postal code
94110
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Chamber, Patient Isolation
Medical specialty description
General Hospital
Regulation number
880.5450
Device class
2
Registration number
3006076009, 3038166862, 3023194188, 9616096, 3010844918, 3014421917
FEI number
3003807323, 3006076009, 3038166862, 3023194188, 3010844918, 3014421917
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.