EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
FDA 510(k) clearance K990082 · decided 1999-04-09
Clearance details
- K-number
- K990082
- Device name
- EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
- Applicant
- Epic Medical Equipment Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-11
- Decision date
- 1999-04-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.