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FDA 510(k)

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

K-Number: K062363 · 2007-01-17

ApplicantB&W Tek, Inc.
Decision Date2007-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM is the device name listed in this FDA 510(k) record. The listed applicant is B&W Tek, Inc.. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K062363. 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 BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM?

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is B&W Tek, Inc.. The 510(k) number is K062363.

When did BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM receive FDA 510(k) clearance?

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM received FDA 510(k) clearance on 2007-01-17, under 510(k) number K062363.

Who is the listed applicant for BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM?

The FDA 510(k) record lists B&W Tek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM?

The FDA product code for BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM is GEX. This falls under the Gastroenterology category.

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Official Source

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

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