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FDA 510(k)

AUDIO TECHNOLOGIES S:R.1

K-Number: K001142 · 2000-06-23

ApplicantAudio Technologies S.R.L.
Decision Date2000-06-23
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIO TECHNOLOGIES S:R.1 is the device name listed in this FDA 510(k) record. The listed applicant is Audio Technologies S.R.L.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001142. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIO TECHNOLOGIES S:R.1?

AUDIO TECHNOLOGIES S:R.1 is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Audio Technologies S.R.L.. The 510(k) number is K001142.

When did AUDIO TECHNOLOGIES S:R.1 receive FDA 510(k) clearance?

AUDIO TECHNOLOGIES S:R.1 received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001142.

Who is the listed applicant for AUDIO TECHNOLOGIES S:R.1?

The FDA 510(k) record lists Audio Technologies S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIO TECHNOLOGIES S:R.1?

The FDA product code for AUDIO TECHNOLOGIES S:R.1 is ETB.

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Other records listing Audio Technologies S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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