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FDA 510(k)

MAX IT

K-Number: K983438 · 1999-02-08

ApplicantDorea, Inc.
Decision Date1999-02-08
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAX IT is the device name listed in this FDA 510(k) record. The listed applicant is Dorea, Inc.. It received FDA 510(k) clearance on 1999-02-08 under 510(k) number K983438. 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 MAX IT?

MAX IT is a medical device that received FDA 510(k) clearance on 1999-02-08. The listed applicant is Dorea, Inc.. The 510(k) number is K983438.

When did MAX IT receive FDA 510(k) clearance?

MAX IT received FDA 510(k) clearance on 1999-02-08, under 510(k) number K983438.

Who is the listed applicant for MAX IT?

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

What is the FDA product code for MAX IT?

The FDA product code for MAX IT is LKY.

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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