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FDA 510(k)

BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B

K-Number: K070195 · 2007-10-15

ApplicantBroadsound Corporation
Decision Date2007-10-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B is the device name listed in this FDA 510(k) record. The listed applicant is Broadsound Corporation. It received FDA 510(k) clearance on 2007-10-15 under 510(k) number K070195. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B?

BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B is a medical device that received FDA 510(k) clearance on 2007-10-15. The listed applicant is Broadsound Corporation. The 510(k) number is K070195.

When did BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B receive FDA 510(k) clearance?

BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B received FDA 510(k) clearance on 2007-10-15, under 510(k) number K070195.

Who is the listed applicant for BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B?

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

What is the FDA product code for BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B?

The FDA product code for BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B is ITX.

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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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