DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES— 510(k) K080366
Substantially EquivalentZefon Intl.
FDA 510(k) clearance K080366 for DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES, Substantially Equivalent on 2008-06-09. Applicant: Zefon Intl.. Device class: 2.
Clearance details
- Applicant
- Zefon Intl.
- Product code
- Code DXQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Ocala, FL, US
Recent devices under product code DXQ
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- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
More clearances from Zefon Intl.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.