Parks Medical Electronics, Inc
FDA Regulatory Profile
Parks Medical Electronics, Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0443-2013, Class II) was initiated on August 8, 2012. Its most recent 510(k) clearance was granted on June 2, 1995.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0443-2013 | Class II | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are va | August 8, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K944495 | MODEL 3200 VASCULAR MINI-LAB | June 2, 1995 |