Skip to content

Stellate Systems

CanadaFDA applicant, unverified

Devices
7
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Stellate Systems makes

Stellate Systems makes EEG systems and ambulatory recorders, including the LUNA, HARMONE-SCHWARZER EEG SYSTEM, RHYTHM, ECLIPSE VERSION 3.0, NOTTA AMBULATORY RECORDER, HARMONIE SYSTEM, and HARMONIE SENSA devices.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

  • Luna Ref K982351

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Harmone-Schwarzer Eeg System Ref K010728

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rhythm Ref K912938

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Eclipse Version 3.0 Ref K955577

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Notta Ambulatory Recorder Ref K013450

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Harmonie System Ref K083577

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Harmonie Sensa Ref K960273

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Stellate Systems, the earliest on 2009-04-06 and the most recent on 2009-04-16. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use and 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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 16 Apr 2009 Z-0487-2012 Unclassified (pre-2012) Terminated The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America. Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Denmark, Greece, Hong Kong, Hungary,…
      Full distribution text Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Denmark, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Norway, Rep. DE Panama, Spain, Switzerland, Taiwan ROC, and Turkey.
    • 6 Apr 2009 Z-1080-2013 Class II Terminated The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA. Distribution: Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA,…
      Full distribution text Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom.
      Submission numbers: K010728, K083577

Frequently asked questions

How many devices does Stellate Systems have in the registry?

The registry currently lists 7 devices for Stellate Systems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stellate Systems's devices?

Among its 7 most recently registered devices, Stellate Systems has devices listed in FDA 510(k) (7 devices).

What risk classes do Stellate Systems's devices fall under?

Among its 7 most recently registered devices, the classes recorded for Stellate Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stellate Systems?

FDA recall records list 2 recalls initiated by Stellate Systems, the most recent initiated on 16 Apr 2009. 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 Stellate Systems in the registry?

The most recently registered devices listed for Stellate Systems include LUNA, HARMONE-SCHWARZER EEG SYSTEM, RHYTHM and ECLIPSE VERSION 3.0.

Generated automatically from registry data and not verified by a human reviewer.