BC (Body Composition Software)

FDA 510(k) K070999 · Rjl Systems, Inc.

Substantially Equivalent

510(k) numberK070999

Submission

Device name
BC (Body Composition Software)
Applicant
Rjl Systems, Inc.
Clinton Twp, MI, US
Received
April 9, 2007
Decision date
August 2, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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Questions and answers

When was BC (Body Composition Software) cleared by the FDA?

BC (Body Composition Software) (K070999) received a 510(k) decision of Substantially Equivalent on August 2, 2007, 115 days after the submission was received.

What is the product code of K070999?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.