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FDA 510(k)

Personalized Therapy Comfort Settings (PTCS)

K-Number: K251657 · 2025-12-05

ApplicantResmed Corp
Decision Date2025-12-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Personalized Therapy Comfort Settings (PTCS) is a medical device manufactured by Resmed Corp. It received FDA 510(k) clearance on 2025-12-05 under approval number K251657. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Personalized Therapy Comfort Settings (PTCS)?

Personalized Therapy Comfort Settings (PTCS) is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Resmed Corp. The 510(k) number is K251657.

When was Personalized Therapy Comfort Settings (PTCS) approved by the FDA?

Personalized Therapy Comfort Settings (PTCS) received FDA 510(k) clearance on 2025-12-05, under approval number K251657.

What company makes Personalized Therapy Comfort Settings (PTCS)?

Personalized Therapy Comfort Settings (PTCS) is manufactured by Resmed Corp.

What is the FDA product code for Personalized Therapy Comfort Settings (PTCS)?

The FDA product code for Personalized Therapy Comfort Settings (PTCS) is BZD.

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Related PubMed Literature

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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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