Accurkardia, Inc.
United StatesFDA applicant, unverified FDA FEI 3045498928
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Accurkardia, Inc. makes
Accurkardia, Inc. manufactures the AccurECG Analysis System, a medical device designed for electrocardiogram (ECG) analysis and interpretation, available in versions 2.0 and earlier.
The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
AccurECG Analysis System (v2.0) Ref K252361
Regimes: 510(k) Registry: 510(k)AccurECG Analysis System Ref K223013
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045498928
- Address
- 101 Avenue Of The Americas Ste 931, New York, NY, 10013
Frequently asked questions
How many devices does Accurkardia, Inc. have in the registry?
The registry currently lists 2 devices for Accurkardia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accurkardia, Inc.'s devices?
Among its 2 most recently registered devices, Accurkardia, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Accurkardia, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Accurkardia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accurkardia, Inc. in the registry?
The most recently registered devices listed for Accurkardia, Inc. include AccurECG Analysis System (v2.0) and AccurECG Analysis System.