FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
FDA 510(k) clearance K041644 · decided 2004-07-29
Clearance details
- K-number
- K041644
- Device name
- FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
- Applicant
- Elekon Industries U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-17
- Decision date
- 2004-07-29
- Days to decision
- 42 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.