LGM
- Product code
- LGM
- Device name
- Chamber, Patient Isolation
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5450
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 12
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231256 | 2024-01-03 | Carecubes, Inc. | Carecube Negative Pressure Isolation Chamber |
Official FDA classification page: LGM
Classification and pathway per current FDA publications. Data from openFDA (CC0).