510(k) K210894
K210894 is an FDA 510(k) premarket notification submitted by Panacea Medical Technologies Pvt. , Ltd. for the device "SIDDHARTH-II; IMPACT". The FDA issued a decision of Substantially Equivalent on September 28, 2021. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Panacea Medical Technologies Pvt. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2021
- Date Received
- March 25, 2021
- 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