DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100— 510(k) K080854
Substantially EquivalentSuntech Medical, Inc.
FDA 510(k) clearance K080854 for DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100, Substantially Equivalent on 2008-10-20. Applicant: Suntech Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Suntech Medical, Inc.
- 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
- Morrisville, NC, US
Recent devices under product code DXQ
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- K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
More clearances from Suntech Medical, Inc.
view allRecalls naming K080854
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080854.
Data sourced from openFDA. This site is unofficial and independent of the FDA.