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FDA 510(k)

Hemosure Accu-Reader A100

K-Number: K200754 · 2022-06-02

ApplicantW.H.P.M., Inc.
Decision Date2022-06-02
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Hemosure Accu-Reader A100 is the device name listed in this FDA 510(k) record. The listed applicant is W.H.P.M., Inc.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K200754. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemosure Accu-Reader A100?

Hemosure Accu-Reader A100 is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K200754.

When did Hemosure Accu-Reader A100 receive FDA 510(k) clearance?

Hemosure Accu-Reader A100 received FDA 510(k) clearance on 2022-06-02, under 510(k) number K200754.

Who is the listed applicant for Hemosure Accu-Reader A100?

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

What is the FDA product code for Hemosure Accu-Reader A100?

The FDA product code for Hemosure Accu-Reader A100 is OOX.

Other records listing W.H.P.M., Inc. as applicant

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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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