510(k) K042705
K042705 is an FDA 510(k) premarket notification submitted by Elekon Industries U.S.A., Inc. for the device "DISPOSABLE NON-ADHESIVE SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on December 29, 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
- December 29, 2004
- Date Received
- September 30, 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