DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440— 510(k) K990115
Substantially EquivalentMaersk Medical A/S
FDA 510(k) clearance K990115 for DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440, Substantially Equivalent on 1999-12-06. Applicant: Maersk Medical A/S. Device class: 2.
Clearance details
- Applicant
- Maersk Medical 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
- Fort Worth, TX, US
Recent devices under product code DRX
view allMore clearances from Maersk Medical A/S
view all- K011071 — PARADIGM QUICK-SET INFUSION SET
- K002138 — PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
- K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
- K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
- K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
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.