SENSICARDIAC— 510(k) K121617
Substantially EquivalentDiacoustic Medical (Pty)
FDA 510(k) clearance K121617 for SENSICARDIAC, Substantially Equivalent on 2012-07-27. Applicant: Diacoustic Medical (Pty). Device class: 2.
Clearance details
- Applicant
- Diacoustic Medical (Pty)
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
Recent devices under product code DQD
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