QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V— 510(k) K072060
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K072060 for QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V, Substantially Equivalent on 2007-08-17. Applicant: Nihon Kohden America, Inc..
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foothill, CA, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.