510(k) K242066
K242066 is an FDA 510(k) premarket notification submitted by Amalgam Rx, Inc. for the device "iSage Rx". The FDA issued a decision of Substantially Equivalent on August 21, 2024. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2024
- Date Received
- July 15, 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