Fidelity Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Fidelity Medical, Inc. makes
Fidelity Medical, Inc. manufactures electrocardiograph machines, including the LP-PLUS, LP-3, and LP-3000 high-resolution models, which record and display cardiac electrical activity. The company also produces clinical electronic thermometers and portable cardiac imaging devices, such as the FLUOROPLUA Cardiac and INSTAVIEW systems. Additional offerings include the INSTACINE and INSTACINE D-2000 for cardiac monitoring, as well as the INSTASPOT for diagnostic imaging.
These devices are classified under FDA categories Class I and Class II, with regulatory submissions supported through the 510(k) clearance pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Instacine Ref K942558
Regimes: 510(k) Registry: 510(k)Fluoroplua Cardiac And/Or Instaview Ref K941917
Regimes: 510(k) Registry: 510(k)LP-Plus Ref K903774
Regimes: 510(k) Registry: 510(k)Instacine D-2000 Ref K983088
Regimes: 510(k) Registry: 510(k)Clinical Electronic Thermometer Ref K841780
Regimes: 510(k) Registry: 510(k)LP-3 Electrocardiograph Ref K864614
Regimes: 510(k) Registry: 510(k)Instaspot Ref K942504
Regimes: 510(k) Registry: 510(k)LP-3000 High Resolution Electrocardiograph Ref K872928
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fidelity Medical, Inc. have in the registry?
The registry currently lists 8 devices for Fidelity Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fidelity Medical, Inc.'s devices?
Among its 8 most recently registered devices, Fidelity Medical, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Fidelity Medical, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Fidelity Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fidelity Medical, Inc. in the registry?
The most recently registered devices listed for Fidelity Medical, Inc. include INSTACINE, FLUOROPLUA CARDIAC AND/OR INSTAVIEW, LP-PLUS and INSTACINE D-2000.