K231256 is an FDA 510(k) clearance for the Carecube Negative Pressure Isolation Chamber. This device is classified as a Chamber, Patient Isolation (Class II - Special Controls, product code LGM).
Submitted by Carecubes, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 3, 2024, 247 days after receiving the submission on May 1, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5450.
| 510(k) Number | K231256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2023 |
| Decision Date | January 03, 2024 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGM - Chamber, Patient Isolation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5450 |