iSage Rx— 510(k) K242066
Substantially EquivalentAmalgam Rx, Inc.
FDA 510(k) clearance K242066 for iSage Rx, Substantially Equivalent on 2024-08-21. Applicant: Amalgam Rx, Inc..
Clearance details
- Applicant
- Amalgam Rx, Inc.
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.