510(k) K200443
K200443 is an FDA 510(k) premarket notification submitted by Monarch Medical Technologies, LLC for the device "EndoTool IV 1.10". The FDA issued a decision of Substantially Equivalent on March 17, 2020. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Monarch Medical Technologies, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2020
- Date Received
- February 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type