CAIRE DIAGNOSTICS INC
FDA Regulatory Profile
CAIRE DIAGNOSTICS INC appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1284-2021, Class II) was initiated on February 26, 2021. Its most recent 510(k) clearance was granted on June 7, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1284-2021 | Class II | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to | February 26, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213611 | Fenom Pro | June 7, 2023 |