510(k) K243354
K243354 is an FDA 510(k) premarket notification submitted by Deka Research & Development Corp. for the device "Remunity System". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code QJY (Infusion Pump, Drug Specific, Pharmacy-Filled), a Class II device regulated under 21 CFR 880.5725. Deka Research & Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2024
- Date Received
- October 29, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infusion Pump, Drug Specific, Pharmacy-Filled
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.