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FDA 510(k)

SPECTRA SP II, SPECTRA DENTA II

K-Number: K091320 · 2009-08-19

ApplicantLutronic Corporation
Decision Date2009-08-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA SP II, SPECTRA DENTA II is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2009-08-19 under 510(k) number K091320. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA SP II, SPECTRA DENTA II?

SPECTRA SP II, SPECTRA DENTA II is a medical device that received FDA 510(k) clearance on 2009-08-19. The listed applicant is Lutronic Corporation. The 510(k) number is K091320.

When did SPECTRA SP II, SPECTRA DENTA II receive FDA 510(k) clearance?

SPECTRA SP II, SPECTRA DENTA II received FDA 510(k) clearance on 2009-08-19, under 510(k) number K091320.

Who is the listed applicant for SPECTRA SP II, SPECTRA DENTA II?

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

What is the FDA product code for SPECTRA SP II, SPECTRA DENTA II?

The FDA product code for SPECTRA SP II, SPECTRA DENTA II is GEX. This falls under the Gastroenterology category.

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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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