Qrs Diagnostic, LLC
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Qrs Diagnostic, LLC makes
Qrs Diagnostic, LLC manufactures diagnostic cardiology devices, including modifications to the BPCARD system (Model Z-7000-0700) for electrocardiogram (ECG) monitoring, as well as standalone ECG analysis systems like the EKGCARD. The company also produces spirometry and pulse oximetry tools, such as the SpiroxCard diagnostic spirometer with pulse oximeter, the Sensaire diagnostic spirometer, and the SpiroCard for respiratory function testing. Additional offerings include the CardioView32 review module for ECG data analysis.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Modification To: Bpcard, Model Z-7000-0700 Ref K073630
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sensaire Diagnostic Spirometer Ref K001278
Regimes: 510(k) Registry: 510(k)CARDIOVIEW32 Review Module Ref K083749
Regimes: 510(k) Registry: 510(k)Ekgcard System Ref K030535
Regimes: 510(k) Registry: 510(k)Spirocard Ref K973138
Regimes: 510(k) Registry: 510(k)Bpcard Ref K031964
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Qrs Diagnostic, LLC, initiated on 2012-02-16. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 16 Feb 2012 Z-1315-2012 Not yet classified Terminated QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretatio
Frequently asked questions
How many devices does Qrs Diagnostic, LLC have in the registry?
The registry currently lists 7 devices for Qrs Diagnostic, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qrs Diagnostic, LLC's devices?
Among its 7 most recently registered devices, Qrs Diagnostic, LLC has devices listed in FDA 510(k) (7 devices).
What risk classes do Qrs Diagnostic, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Qrs Diagnostic, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Qrs Diagnostic, LLC?
FDA recall records list 1 recall initiated by Qrs Diagnostic, LLC, the most recent initiated on 16 Feb 2012. 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 Qrs Diagnostic, LLC in the registry?
The most recently registered devices listed for Qrs Diagnostic, LLC include MODIFICATION TO: BPCARD, MODEL Z-7000-0700, SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER, SENSAIRE DIAGNOSTIC SPIROMETER and CARDIOVIEW32 REVIEW MODULE.