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FDA 510(k)

VIBRO-TRAC

K-Number: K092731 · 2010-06-10

ApplicantPneumex, Inc.
Decision Date2010-06-10
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VIBRO-TRAC is the device name listed in this FDA 510(k) record. The listed applicant is Pneumex, Inc.. It received FDA 510(k) clearance on 2010-06-10 under 510(k) number K092731. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIBRO-TRAC?

VIBRO-TRAC is a medical device that received FDA 510(k) clearance on 2010-06-10. The listed applicant is Pneumex, Inc.. The 510(k) number is K092731.

When did VIBRO-TRAC receive FDA 510(k) clearance?

VIBRO-TRAC received FDA 510(k) clearance on 2010-06-10, under 510(k) number K092731.

Who is the listed applicant for VIBRO-TRAC?

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

What is the FDA product code for VIBRO-TRAC?

The FDA product code for VIBRO-TRAC is JFB.

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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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