BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY— 510(k) K013717
Substantially EquivalentBrentwood Medical Technology Corp.
FDA 510(k) clearance K013717 for BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY, Substantially Equivalent on 2002-02-06. Applicant: Brentwood Medical Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Brentwood Medical Technology Corp.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, US
Recent devices under product code DPS
view allMore clearances from Brentwood Medical Technology Corp.
view allAdverse 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.