FLEXI-STAT SP02 EAR SENSOR— 510(k) K042675
Substantially EquivalentElekon Industries U.S.A., Inc.
FDA 510(k) clearance K042675 for FLEXI-STAT SP02 EAR SENSOR, Substantially Equivalent on 2004-12-06. Applicant: Elekon Industries U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Elekon Industries U.S.A., Inc.
- Product code
- Code DPZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2710
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code DPZ
view allMore clearances from Elekon Industries U.S.A., Inc.
view all- K042705 — DISPOSABLE NON-ADHESIVE SPO2 SENSORS
- K042704 — REUSABLE FINGER CLIP SPO2 SENSORS
- K041522 — FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
- K041647 — FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
- K041644 — FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.