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

FDA 510(k)

Ventilator, Non-continuous (Respirator)

K-Number: K201439 · 2020-09-25

ApplicantRespironics, Inc.
Decision Date2020-09-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ventilator, Non-continuous (Respirator) is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K201439. 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 Ventilator, Non-continuous (Respirator)?

Ventilator, Non-continuous (Respirator) is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Respironics, Inc.. The 510(k) number is K201439.

When did Ventilator, Non-continuous (Respirator) receive FDA 510(k) clearance?

Ventilator, Non-continuous (Respirator) received FDA 510(k) clearance on 2020-09-25, under 510(k) number K201439.

Who is the listed applicant for Ventilator, Non-continuous (Respirator)?

The FDA 510(k) record lists Respironics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ventilator, Non-continuous (Respirator)?

The FDA product code for Ventilator, Non-continuous (Respirator) is BZD.

Other records listing Respironics, Inc. 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.

K243394AF531 Oro-Nasal SE Face MaskK231313Therapy Mask 3100 NC/SPK210844DreamWear Silicone Pillows MaskK210386Magneto Nasal MaskK202142Sleepware G3K200480DreamStation 2 System, DreamStation 2 Advanced System

View all 15 devices →

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend 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.

↑