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FDA 510(k)

DEKA PHYSIQ 360

K-Number: K231971 · 2023-09-26

ApplicantEl.En S.P.A.
Decision Date2023-09-26
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA PHYSIQ 360 is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K231971. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA PHYSIQ 360?

DEKA PHYSIQ 360 is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is El.En S.P.A.. The 510(k) number is K231971.

When did DEKA PHYSIQ 360 receive FDA 510(k) clearance?

DEKA PHYSIQ 360 received FDA 510(k) clearance on 2023-09-26, under 510(k) number K231971.

Who is the listed applicant for DEKA PHYSIQ 360?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA PHYSIQ 360?

The FDA product code for DEKA PHYSIQ 360 is PKT.

Other records listing El.En S.P.A. 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.

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Related Devices (Code: PKT)

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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