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FDA 510(k)

FREEMIE (R)

K-Number: K111411 · 2012-02-01

ApplicantDao Health
Decision Date2012-02-01
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FREEMIE (R) is the device name listed in this FDA 510(k) record. The listed applicant is Dao Health. It received FDA 510(k) clearance on 2012-02-01 under 510(k) number K111411. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEMIE (R)?

FREEMIE (R) is a medical device that received FDA 510(k) clearance on 2012-02-01. The listed applicant is Dao Health. The 510(k) number is K111411.

When did FREEMIE (R) receive FDA 510(k) clearance?

FREEMIE (R) received FDA 510(k) clearance on 2012-02-01, under 510(k) number K111411.

Who is the listed applicant for FREEMIE (R)?

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

What is the FDA product code for FREEMIE (R)?

The FDA product code for FREEMIE (R) is HGX.

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Other records listing Dao Health 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.

K172772Freemie Independence, Freemie LibertyK130349FREEMIE BREAST COLLECTION SYSTEM

Related Devices (Code: HGX)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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