PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES— 510(k) K992524
Substantially EquivalentAdvantage Medical Electronics, Inc.
FDA 510(k) clearance K992524 for PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES, Substantially Equivalent on 2000-03-01. Applicant: Advantage Medical Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Advantage Medical Electronics, Inc.
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coral Springs, FL, US
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Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.