BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES— 510(k) K983689
Substantially EquivalentMedicotest A/S
FDA 510(k) clearance K983689 for BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES, Substantially Equivalent on 1999-01-15. Applicant: Medicotest A/S. Device class: 2.
Clearance details
- Applicant
- Medicotest A/S
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code DRX
view allMore clearances from Medicotest A/S
view all- K020382 — BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
- K020907 — NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
- K002079 — MULTI-FUNCTION DEFIBRILLATION ELECTRODE
- K001869 — DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
- K973529 — NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
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.