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FDA 510(k)

SYSTEM-ARMS, MODELS 390, X60

K-Number: K083164 · 2008-12-16

ApplicantBio-Medical Research, Ltd.
Decision Date2008-12-16
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SYSTEM-ARMS, MODELS 390, X60 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K083164. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM-ARMS, MODELS 390, X60?

SYSTEM-ARMS, MODELS 390, X60 is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K083164.

When did SYSTEM-ARMS, MODELS 390, X60 receive FDA 510(k) clearance?

SYSTEM-ARMS, MODELS 390, X60 received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083164.

Who is the listed applicant for SYSTEM-ARMS, MODELS 390, X60?

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

What is the FDA product code for SYSTEM-ARMS, MODELS 390, X60?

The FDA product code for SYSTEM-ARMS, MODELS 390, X60 is NGX.

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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.

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