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)

Magneto Nasal Mask

K-Number: K210386 · 2021-07-12

Decision Date2021-07-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Magneto Nasal Mask is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2021-07-12 under approval number K210386. 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 Magneto Nasal Mask?

Magneto Nasal Mask is a medical device that received FDA 510(k) clearance on 2021-07-12. It is manufactured by Respironics, Inc.. The 510(k) number is K210386.

When was Magneto Nasal Mask approved by the FDA?

Magneto Nasal Mask received FDA 510(k) clearance on 2021-07-12, under approval number K210386.

What company makes Magneto Nasal Mask?

Magneto Nasal Mask is manufactured by Respironics, Inc..

What is the FDA product code for Magneto Nasal Mask?

The FDA product code for Magneto Nasal Mask is BZD.

Other Devices by Respironics, Inc.

View all 15 devices →

Related Devices (Code: BZD)

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.