510(k) K100801
K100801 is an FDA 510(k) premarket notification submitted by Prowess, Inc. for the device "PUMA MODEL VERSION 1.0". The FDA issued a decision of Substantially Equivalent on Jun 18, 2010. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Prowess, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 2010
- Date Received
- Mar 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type