510(k) K151790
K151790 is an FDA 510(k) premarket notification submitted by Pmt Corporation for the device "PMT Platinum Depthalon Depth Electrode". The FDA issued a decision of Substantially Equivalent on July 14, 2016. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Pmt Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2016
- Date Received
- July 1, 2015
- 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