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FDA 510(k)

COMPANION 2800 VOLUME VENTILATOR

K-Number: K851366 · 1985-10-23

ApplicantPuritan Bennett Corp.
Decision Date1985-10-23
Product Code
DecisionSubstantially Equivalent

Device Summary

COMPANION 2800 VOLUME VENTILATOR 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 1985-10-23 under 510(k) number K851366. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPANION 2800 VOLUME VENTILATOR?

COMPANION 2800 VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K851366.

When did COMPANION 2800 VOLUME VENTILATOR receive FDA 510(k) clearance?

COMPANION 2800 VOLUME VENTILATOR received FDA 510(k) clearance on 1985-10-23, under 510(k) number K851366.

Who is the listed applicant for COMPANION 2800 VOLUME VENTILATOR?

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

Related Clinical Trials

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.

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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

View all 110 devices →

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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