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FDA 510(k)

COMPANION 50 REGULATOR/FLOWMETER

K-Number: K872443 · 1987-07-21

ApplicantPuritan Bennett Corp.
Decision Date1987-07-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPANION 50 REGULATOR/FLOWMETER 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 1987-07-21 under 510(k) number K872443. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPANION 50 REGULATOR/FLOWMETER?

COMPANION 50 REGULATOR/FLOWMETER is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K872443.

When did COMPANION 50 REGULATOR/FLOWMETER receive FDA 510(k) clearance?

COMPANION 50 REGULATOR/FLOWMETER received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872443.

Who is the listed applicant for COMPANION 50 REGULATOR/FLOWMETER?

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 COMPANION 50 REGULATOR/FLOWMETER?

The FDA product code for COMPANION 50 REGULATOR/FLOWMETER is DRT.

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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: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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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