510(k) K973834
K973834 is an FDA 510(k) premarket notification submitted by Pausch Corp. for the device "CS2000 & CS2000 TOMO". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Pausch Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1998
- Date Received
- October 8, 1997
- 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