510(k) K181544
K181544 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corporation for the device "Anchor Bolt (as an accessory to Depth Electrodes)". The FDA issued a decision of Substantially Equivalent on August 9, 2018. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2018
- Date Received
- June 12, 2018
- 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