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FDA 510(k)

FSC 2

K-Number: K090601 · 2009-05-11

ApplicantSchoelly Imaging, Inc.
Decision Date2009-05-11
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FSC 2 is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Imaging, Inc.. It received FDA 510(k) clearance on 2009-05-11 under 510(k) number K090601. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FSC 2?

FSC 2 is a medical device that received FDA 510(k) clearance on 2009-05-11. The listed applicant is Schoelly Imaging, Inc.. The 510(k) number is K090601.

When did FSC 2 receive FDA 510(k) clearance?

FSC 2 received FDA 510(k) clearance on 2009-05-11, under 510(k) number K090601.

Who is the listed applicant for FSC 2?

The FDA 510(k) record lists Schoelly Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FSC 2?

The FDA product code for FSC 2 is NTN.

Other records listing Schoelly Imaging, Inc. 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.

K090800VS-100 ILLUMINATION AND IMAGING SYSTEMK083553NASO-LARYNGO-PHARYNGOSCOPEK060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEK053412FLEXISCOPE, MODELS 50MH AND 50 MHC

Related Devices (Code: NTN)

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.

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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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