NEWCOR— 510(k) K020440
Substantially EquivalentSiemens Medical Systems, Inc.
FDA 510(k) clearance K020440 for NEWCOR, Substantially Equivalent on 2002-12-03. Applicant: Siemens Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Systems, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Recent devices under product code DQK
view allMore clearances from Siemens Medical Systems, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K020440
K-number listed on FDA's recall record- Z-2688-2017 — Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
- Z-2156-2017 — AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020440.
Data sourced from openFDA. This site is unofficial and independent of the FDA.