510(k) K130368
K130368 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "AUTOLITH TOUCH; URO TOUCH". The FDA issued a decision of Substantially Equivalent on November 15, 2013. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2013
- Date Received
- February 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Electro-Hydraulic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type