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FDA 510(k)

FISIOWARM 7.0

K-Number: K232966 · 2024-12-26

ApplicantGolden Star Srl
Decision Date2024-12-26
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FISIOWARM 7.0 is a medical device manufactured by Golden Star Srl. It received FDA 510(k) clearance on 2024-12-26 under approval number K232966. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISIOWARM 7.0?

FISIOWARM 7.0 is a medical device that received FDA 510(k) clearance on 2024-12-26. It is manufactured by Golden Star Srl. The 510(k) number is K232966.

When was FISIOWARM 7.0 approved by the FDA?

FISIOWARM 7.0 received FDA 510(k) clearance on 2024-12-26, under approval number K232966.

What company makes FISIOWARM 7.0?

FISIOWARM 7.0 is manufactured by Golden Star Srl.

What is the FDA product code for FISIOWARM 7.0?

The FDA product code for FISIOWARM 7.0 is PBX.

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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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