510(k) K201279
K201279 is an FDA 510(k) premarket notification submitted by Geomed Medizin-Technik GmbH & Co. KG for the device "ASSISTO Universal Applicator Clamping Device". The FDA issued a decision of Substantially Equivalent on Jul 10, 2020. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Geomed Medizin-Technik GmbH & Co. KG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2020
- Date Received
- May 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type
- 510(k)