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FDA 510(k)

COMPANION OXYGEN SAVER

K-Number: K863695 · 1986-10-15

ApplicantPuritan Bennett Corp.
Decision Date1986-10-15
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPANION OXYGEN SAVER 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 1986-10-15 under 510(k) number K863695. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPANION OXYGEN SAVER?

COMPANION OXYGEN SAVER is a medical device that received FDA 510(k) clearance on 1986-10-15. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K863695.

When did COMPANION OXYGEN SAVER receive FDA 510(k) clearance?

COMPANION OXYGEN SAVER received FDA 510(k) clearance on 1986-10-15, under 510(k) number K863695.

Who is the listed applicant for COMPANION OXYGEN SAVER?

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 OXYGEN SAVER?

The FDA product code for COMPANION OXYGEN SAVER is NFB.

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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: NFB)

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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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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