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FDA 510(k)

ECHO BLASTER

K-Number: K102253 · 2011-03-14

ApplicantTelemed
Decision Date2011-03-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHO BLASTER is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2011-03-14 under 510(k) number K102253. 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 ECHO BLASTER?

ECHO BLASTER is a medical device that received FDA 510(k) clearance on 2011-03-14. The listed applicant is Telemed. The 510(k) number is K102253.

When did ECHO BLASTER receive FDA 510(k) clearance?

ECHO BLASTER received FDA 510(k) clearance on 2011-03-14, under 510(k) number K102253.

Who is the listed applicant for ECHO BLASTER?

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

What is the FDA product code for ECHO BLASTER?

The FDA product code for ECHO BLASTER is IYO.

Related Clinical Trials

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.

Other records listing Telemed 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.

Related Devices (Code: IYO)

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.

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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