510(k) K141230
K141230 is an FDA 510(k) premarket notification submitted by Mobius Medical Systems, LP for the device "DOSELAB PRO". The FDA issued a decision of Substantially Equivalent on August 27, 2014. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Mobius Medical Systems, LP has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2014
- Date Received
- May 13, 2014
- 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