MEDICOTEST ECG ELECTRODES— 510(k) K961643
Substantially EquivalentMedicotest, Inc.
FDA 510(k) clearance K961643 for MEDICOTEST ECG ELECTRODES, Substantially Equivalent on 1996-12-09. Applicant: Medicotest, Inc.. Device class: 2.
Clearance details
- Applicant
- Medicotest, Inc.
- 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
- St. Louis, MO, US
Recent devices under product code DRX
view allMore clearances from Medicotest, Inc.
view all- K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
- K970639 — NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
- K952176 — DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K
- K941568 — K-10-VS, DA-05-VS, RECORDING ELECTRODES
- K931426 — NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE
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.