510(k) K191739
K191739 is an FDA 510(k) premarket notification submitted by Alpha Omega Engineering , Ltd. for the device "Sterile LeadConfirm". The FDA issued a decision of Substantially Equivalent on January 2, 2020. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Alpha Omega Engineering , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2020
- Date Received
- June 28, 2019
- 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