FDA 510(k)

Seer Home

K-Number: K212788 · 2022-06-16

Decision Date2022-06-16

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Seer Home is the device name listed in this FDA 510(k) record. The listed applicant is Seer Medical Pty, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K212788. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seer Home?

Seer Home is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Seer Medical Pty, Ltd.. The 510(k) number is K212788.

When did Seer Home receive FDA 510(k) clearance?

Seer Home received FDA 510(k) clearance on 2022-06-16, under 510(k) number K212788.

Who is the listed applicant for Seer Home?

The FDA 510(k) record lists Seer Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Seer Home?

The FDA product code for Seer Home is GWQ.

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.