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FDA 510(k)

BREEZE SLEEPGEAR WITH DREAMSEAL

K-Number: K002001 · 2000-09-06

ApplicantPuritan Bennett Corp.
Decision Date2000-09-06
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREEZE SLEEPGEAR WITH DREAMSEAL is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 2000-09-06 under 510(k) number K002001. 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 BREEZE SLEEPGEAR WITH DREAMSEAL?

BREEZE SLEEPGEAR WITH DREAMSEAL is a medical device that received FDA 510(k) clearance on 2000-09-06. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K002001.

When did BREEZE SLEEPGEAR WITH DREAMSEAL receive FDA 510(k) clearance?

BREEZE SLEEPGEAR WITH DREAMSEAL received FDA 510(k) clearance on 2000-09-06, under 510(k) number K002001.

Who is the listed applicant for BREEZE SLEEPGEAR WITH DREAMSEAL?

The FDA 510(k) record lists Puritan Bennett Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREEZE SLEEPGEAR WITH DREAMSEAL?

The FDA product code for BREEZE SLEEPGEAR WITH DREAMSEAL is BZD.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840

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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.

K261262Altis Full Face MaskRespironics, Inc.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.

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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