510(k) K241088
K241088 is an FDA 510(k) premarket notification submitted by Monarch Medical Technologies for the device "EndoTool IV (3.1)". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Monarch Medical Technologies has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2024
- Date Received
- April 19, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type