510(k) K132547
K132547 is an FDA 510(k) premarket notification submitted by Monarch Medical Technologies for the device "ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)". The FDA issued a decision of Substantially Equivalent on April 17, 2014. 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
- April 17, 2014
- Date Received
- August 13, 2013
- Clearance Type
- Abbreviated
- 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