FDA 510(k)

BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900

K-Number: K071884 · 2007-08-09

Decision Date2007-08-09

Product CodeMNW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 is the device name listed in this FDA 510(k) record. The listed applicant is Jawon Medical Co., Ltd.. It received FDA 510(k) clearance on 2007-08-09 under 510(k) number K071884. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900?

BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 is a medical device that received FDA 510(k) clearance on 2007-08-09. The listed applicant is Jawon Medical Co., Ltd.. The 510(k) number is K071884.

When did BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 receive FDA 510(k) clearance?

BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 received FDA 510(k) clearance on 2007-08-09, under 510(k) number K071884.

Who is the listed applicant for BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900?

The FDA 510(k) record lists Jawon Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900?

The FDA product code for BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 is MNW.

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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.