Heart Sync Models C-100 and T-100
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K080421 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Heart Sync Models C-100 and T-100 are Automated External Defibrillators (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. These devices are intended for use by trained responders in both pre-hospital and in-hospital settings to treat ventricular fibrillation and pulseless ventricular tachycardia.
The devices are supplied as reusable medical equipment and are regulated under FDA 510(k) clearance (K080421) as Class III devices under regulation number 870.5310. They are intended for single-user operation and must be stored in a clean, dry environment as per manufacturer guidelines. No specific MRI safety information is provided, and their use requires adherence to standard defibrillation protocols and regulatory compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080421 | Class III | Active |
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Manufacturer
- Manufacturer
- Heart Sync, LLC
Sources (1)
- FDA 510(k) K080421 24 fields · synced Sep 18, 2026