HEARTEVENT, MODEL AT— 510(k) K072385
Substantially EquivalentDiagnostic Devices Pty, Ltd.
FDA 510(k) clearance K072385 for HEARTEVENT, MODEL AT, Substantially Equivalent on 2008-01-11. Applicant: Diagnostic Devices Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Devices Pty, Ltd.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eastgardens, AU
Recent devices under product code DXH
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