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FDA 510(k)

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO

K-Number: K080234 · 2008-02-14

ApplicantTeratech Corp.
Decision Date2008-02-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2008-02-14 under 510(k) number K080234. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO?

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Teratech Corp.. The 510(k) number is K080234.

When did TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO receive FDA 510(k) clearance?

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO received FDA 510(k) clearance on 2008-02-14, under 510(k) number K080234.

Who is the listed applicant for TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO?

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

What is the FDA product code for TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO?

The FDA product code for TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO is IYO.

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Other records listing Teratech Corp. 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.

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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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