510(k) K931029
K931029 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "DISPOSABLE CONCENTRIC NEEDLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1994
- Date Received
- March 1, 1993
- Clearance Type
- Traditional
- 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