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FDA 510(k)

PORTABLE OXYGEN SYSTEM

K-Number: K830844 · 1983-05-27

ApplicantPuritan Bennett Corp.
Decision Date1983-05-27
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN SYSTEM 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 1983-05-27 under 510(k) number K830844. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE OXYGEN SYSTEM?

PORTABLE OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K830844.

When did PORTABLE OXYGEN SYSTEM receive FDA 510(k) clearance?

PORTABLE OXYGEN SYSTEM received FDA 510(k) clearance on 1983-05-27, under 510(k) number K830844.

Who is the listed applicant for PORTABLE OXYGEN SYSTEM?

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 PORTABLE OXYGEN SYSTEM?

The FDA product code for PORTABLE OXYGEN SYSTEM is CAN.

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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 OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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Related Devices (Code: CAN)

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.

K162811MR Conditional CGA 870Essex Industries, Inc.K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.K950777OXYGEN REGULATORMada Medical Products, Inc.K942751VANGUARD SERIES GAS REGULATORSBuckman Co., 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.

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