Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Galapogos

K-Number: K200565 · 2021-01-17

ApplicantResmed Corp
Decision Date2021-01-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Galapogos is a medical device manufactured by Resmed Corp. It received FDA 510(k) clearance on 2021-01-17 under approval number K200565. 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 Galapogos?

Galapogos is a medical device that received FDA 510(k) clearance on 2021-01-17. It is manufactured by Resmed Corp. The 510(k) number is K200565.

When was Galapogos approved by the FDA?

Galapogos received FDA 510(k) clearance on 2021-01-17, under approval number K200565.

What company makes Galapogos?

Galapogos is manufactured by Resmed Corp.

What is the FDA product code for Galapogos?

The FDA product code for Galapogos is BZD.

Other Devices by Resmed Corp

K241939EasyCare Tx 2 K241216myAir K251657Personalized Therapy Comfort Settings (PTCS) K250624myAir K251889myAir

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc.

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.

↑