510(k) K071364
K071364 is an FDA 510(k) premarket notification submitted by FHC, Inc. for the device "MICROTARGETING GUIDELINE 4000". The FDA issued a decision of Substantially Equivalent on July 25, 2007. 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
- July 25, 2007
- Date Received
- May 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type