510(k) K041647
K041647 is an FDA 510(k) premarket notification submitted by Elekon Industries U.S.A., Inc. for the device "FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Elekon Industries U.S.A., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2004
- Date Received
- June 17, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type