510(k) K991522
K991522 is an FDA 510(k) premarket notification submitted by FHC, Inc. for the device "MICROTARGETING ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 4, 2000. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. FHC, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2000
- Date Received
- May 3, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type