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FDA 510(k)

Myriad SPECTRA Light Source

K-Number: K232567 · 2024-03-14

ApplicantNico Corporation
Decision Date2024-03-14
Product CodeQFX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Myriad SPECTRA Light Source is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232567. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Myriad SPECTRA Light Source?

Myriad SPECTRA Light Source is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Nico Corporation. The 510(k) number is K232567.

When did Myriad SPECTRA Light Source receive FDA 510(k) clearance?

Myriad SPECTRA Light Source received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232567.

Who is the listed applicant for Myriad SPECTRA Light Source?

The FDA 510(k) record lists Nico Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myriad SPECTRA Light Source?

The FDA product code for Myriad SPECTRA Light Source is QFX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07759648Non-invasive Optical Low-frequency Oscillation Study of the Prefrontal Cortex Based on fNIRSCOMPLETED

Other records listing Nico Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191599NICO Myriad NOVUSK182340NICO MyriadK172433NICO BrainPathK161307NICO MyriadK162075NICO TRIOwand

Related Devices (Code: QFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K240215BLUE 400; BLUE 400 SCarl Zeiss Meditec, AGK211346BLUE 400Carl Zeiss Meditec, AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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