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FDA 510(k)

MEGAVAC SYSTEM

K-Number: K974196 · 1998-05-12

ApplicantBarry J. Kaplan, Inc.
Decision Date1998-05-12
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEGAVAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Barry J. Kaplan, Inc.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K974196. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGAVAC SYSTEM?

MEGAVAC SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Barry J. Kaplan, Inc.. The 510(k) number is K974196.

When did MEGAVAC SYSTEM receive FDA 510(k) clearance?

MEGAVAC SYSTEM received FDA 510(k) clearance on 1998-05-12, under 510(k) number K974196.

Who is the listed applicant for MEGAVAC SYSTEM?

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

What is the FDA product code for MEGAVAC SYSTEM?

The FDA product code for MEGAVAC SYSTEM is LKY.

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Related Devices (Code: LKY)

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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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