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FDA 510(k)

Freespira

K-Number: K180173 · 2018-08-23

ApplicantPalo Alto Health Sciences, Inc.
Decision Date2018-08-23
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Freespira is the device name listed in this FDA 510(k) record. The listed applicant is Palo Alto Health Sciences, Inc.. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K180173. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freespira?

Freespira is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Palo Alto Health Sciences, Inc.. The 510(k) number is K180173.

When did Freespira receive FDA 510(k) clearance?

Freespira received FDA 510(k) clearance on 2018-08-23, under 510(k) number K180173.

Who is the listed applicant for Freespira?

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

What is the FDA product code for Freespira?

The FDA product code for Freespira is HCC.

Related Devices (Code: HCC)

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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