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FDA 510(k)

EXTT-101

K-Number: K082436 · 2009-05-29

ApplicantApimeds, Inc.
Decision Date2009-05-29
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTT-101 is the device name listed in this FDA 510(k) record. The listed applicant is Apimeds, Inc.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K082436. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTT-101?

EXTT-101 is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Apimeds, Inc.. The 510(k) number is K082436.

When did EXTT-101 receive FDA 510(k) clearance?

EXTT-101 received FDA 510(k) clearance on 2009-05-29, under 510(k) number K082436.

Who is the listed applicant for EXTT-101?

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

What is the FDA product code for EXTT-101?

The FDA product code for EXTT-101 is HIR.

Related Devices (Code: HIR)

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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