510(k) K111131
K111131 is an FDA 510(k) premarket notification submitted by Carefusion 209, Inc. for the device "TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES". The FDA issued a decision of Substantially Equivalent on June 17, 2011. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Carefusion 209, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2011
- Date Received
- April 21, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle, Diagnostic Electromyograph
- Device Class
- Class II
- Regulation Number
- 890.1385
- Review Panel
- NE
- Submission Type