SagaTech Electronics, Inc.
FDA Regulatory Profile
SagaTech Electronics, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1725-2013, Class II) was initiated on May 8, 2008. Its most recent 510(k) clearance was granted on June 28, 2002.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1725-2013 | Class II | Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart | May 8, 2008 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K002159 | SNORE SAT RECORDER, MODEL SS41 | June 28, 2002 |