Omikron Scientific, Ltd.
Country not established
- Devices
- 4
What Omikron Scientific, Ltd. makes
Omikron Scientific, Ltd. manufactures unipolar and bipolar pacemakers, including lithium-powered models designed for cardiac rhythm management. The company also produces a modified manufacturing process for Omiderm™, a skin-related medical material, and OmiBand, a wearable device for monitoring or therapeutic applications.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions supported through 510(k) clearances. Omikron Scientific, Ltd. is based in the United States.
Catalogue
Omikron Pacemaker 837 Unipolar & 838 Bipolar Ref K844277
Regimes: 510(k) Registry: 510(k)Lithium Pacemaker 811-811l & 811XL Ref K840748
Regimes: 510(k) Registry: 510(k)Modified Manufacturing Process For Omiderm(Tm) Ref K874480
Regimes: 510(k) Registry: 510(k)Omiband Ref K904445
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omikron Scientific, Ltd. have in the registry?
The registry currently lists 4 devices for Omikron Scientific, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omikron Scientific, Ltd.'s devices?
Among its 4 most recently registered devices, Omikron Scientific, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Omikron Scientific, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Omikron Scientific, Ltd.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Omikron Scientific, Ltd. in the registry?
The most recently registered devices listed for Omikron Scientific, Ltd. include OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR, LITHIUM PACEMAKER 811-811L & 811XL, MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) and OMIBAND.