PMP4 APPLICATION— 510(k) K061428
Substantially EquivalentCard Guard Scientific Survival , Ltd.
FDA 510(k) clearance K061428 for PMP4 APPLICATION, Substantially Equivalent on 2006-10-16. Applicant: Card Guard Scientific Survival , Ltd.. Device class: 2.
Clearance details
- Applicant
- Card Guard Scientific Survival , Ltd.
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code MSX
view allMore clearances from Card Guard Scientific Survival , Ltd.
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- K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
- K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
- K083174 — HEALTHEPOD
Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.