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FDA 510(k)

SQuEEZ Software

K-Number: K201250 · 2020-12-18

ApplicantCardiowise, Inc.
Decision Date2020-12-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SQuEEZ Software is the device name listed in this FDA 510(k) record. The listed applicant is Cardiowise, Inc.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K201250. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SQuEEZ Software?

SQuEEZ Software is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Cardiowise, Inc.. The 510(k) number is K201250.

When did SQuEEZ Software receive FDA 510(k) clearance?

SQuEEZ Software received FDA 510(k) clearance on 2020-12-18, under 510(k) number K201250.

Who is the listed applicant for SQuEEZ Software?

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

What is the FDA product code for SQuEEZ Software?

The FDA product code for SQuEEZ Software is LLZ.

Related Devices (Code: LLZ)

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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