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FDA 510(k)

BOBCAT DX

K-Number: K970543 · 1997-06-26

ApplicantQuest Enabling Designs , Ltd.
Decision Date1997-06-26
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BOBCAT DX is the device name listed in this FDA 510(k) record. The listed applicant is Quest Enabling Designs , Ltd.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K970543. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOBCAT DX?

BOBCAT DX is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Quest Enabling Designs , Ltd.. The 510(k) number is K970543.

When did BOBCAT DX receive FDA 510(k) clearance?

BOBCAT DX received FDA 510(k) clearance on 1997-06-26, under 510(k) number K970543.

Who is the listed applicant for BOBCAT DX?

The FDA 510(k) record lists Quest Enabling Designs , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOBCAT DX?

The FDA product code for BOBCAT DX is IPL.

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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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