510(k) K222762
K222762 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 Jun 8, 2023. 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 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2023
- Date Received
- Sep 13, 2022
- 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
- 510(k)