CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System— 510(k) K231870
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K231870 for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System, Substantially Equivalent on 2023-12-13. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, 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
- Wauwatosa, WI, US
Recent devices under product code DQK
view allMore clearances from Ge Medical Systems Information Technologies, Inc.
view all- K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K251670 — MAC 7 Resting ECG Analysis System
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K233810 — Portrait VSM
Adverse 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 K231870
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 K231870.
Data sourced from openFDA. This site is unofficial and independent of the FDA.