510(k) K941823
K941823 is an FDA 510(k) premarket notification submitted by Elekta Instruments, Inc. for the device "LEKSELL NEURO GENERATOR AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 22, 1996. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Elekta Instruments, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1996
- Date Received
- April 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Lesion, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 882.4400
- Review Panel
- NE
- Submission Type