Brentwood Medical Technology Corp.
Torrance, CA, US
Brentwood Medical Technology Corp. appears in FDA device records in Torrance, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Brentwood Medical Technology Corp. between 2000 and 2011. The busiest year on record is 2000, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103640 | MIDMARK IQECG | DPS | Substantially Equivalent | |
| K100913 | IQVITALS AND IQVITALS SYSTEM | DXN | Substantially Equivalent | |
| K052898 | IQMARK EZ STRESS | DPS | Substantially Equivalent | |
| K031466 | IQMARK DIGITAL HOLTER | MLO | Substantially Equivalent | |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | DPS | Substantially Equivalent | |
| K010505 | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | DPS | Substantially Equivalent | |
| K002499 | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE | BZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2724-2011 | IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient's age. The software does this without notifying the user of the change from use of the Bazett equation, which is utiliz | Terminated | ||
| Z-2726-2011 | IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient's age. The software does this without notifying the user of the change from use of the Bazett equation, which is utiliz | Terminated | ||
| Z-2725-2011 | IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. | The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient's age. The software does this without notifying the user of the change from use of the Bazett equation, which is utiliz | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain