510(k) K013620
K013620 is an FDA 510(k) premarket notification submitted by Medstone Intl., Inc. for the device "MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION". The FDA issued a decision of Substantially Equivalent on January 22, 2002. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Medstone Intl., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2002
- Date Received
- November 5, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type