E100 SERIES SPO2 SENSORS
FDA 510(k) clearance K970098 · decided 1998-04-30
Clearance details
- K-number
- K970098
- Device name
- E100 SERIES SPO2 SENSORS
- Applicant
- Epic Medical Equipment Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-13
- Decision date
- 1998-04-30
- Days to decision
- 472 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225 recall (Z-1188-2008) | Kentec Medical Inc | 2008-06-26 |