Brentwood Medical Technology Corp.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Brentwood Medical Technology Corp. makes
Brentwood Medical Technology Corp. manufactures digital cardiac monitoring and respiratory diagnostic devices, including portable Holter monitors, 12-lead resting ECG analysis systems, and real-time ST-segment and arrhythmia analysis software. Their portfolio also includes digital spirometers with disposable components, stress test systems, and ECG analysis libraries for telemedicine applications.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are intended for use in the United States, where the manufacturer is based.
Catalogue
Iqmark Digital Holter Ref K031466
Regimes: 510(k) Registry: 510(k)Telemed 12 Lead Resting Ecg Analysis Library Ref K010505
Regimes: 510(k) Registry: 510(k)Iqvitals And Iqvitals System Ref K100913
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Iqmark Ez Stress Ref K052898
Regimes: 510(k) Registry: 510(k)Midmark Iqecg Ref K103640
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Brentwood Medical Technology Corp., initiated on 2010-05-18. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 18 May 2010 Z-2724-2011 Unclassified (pre-2012) Terminated 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
- 18 May 2010 Z-2725-2011 Unclassified (pre-2012) Terminated 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
- 18 May 2010 Z-2726-2011 Unclassified (pre-2012) Terminated 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
Frequently asked questions
How many devices does Brentwood Medical Technology Corp. have in the registry?
The registry currently lists 7 devices for Brentwood Medical Technology Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brentwood Medical Technology Corp.'s devices?
Among its 7 most recently registered devices, Brentwood Medical Technology Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Brentwood Medical Technology Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Brentwood Medical Technology Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Brentwood Medical Technology Corp.?
FDA recall records list 3 recalls initiated by Brentwood Medical Technology Corp., the most recent initiated on 18 May 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Brentwood Medical Technology Corp. in the registry?
The most recently registered devices listed for Brentwood Medical Technology Corp. include IQMARK DIGITAL HOLTER, TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY, IQVITALS AND IQVITALS SYSTEM and BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY.