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FDA 510(k)

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE

K-Number: K861435 · 1986-11-07

ApplicantThe John Bunn Co.
Decision Date1986-11-07
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE is the device name listed in this FDA 510(k) record. The listed applicant is The John Bunn Co.. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K861435. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE?

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is The John Bunn Co.. The 510(k) number is K861435.

When did BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE receive FDA 510(k) clearance?

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE received FDA 510(k) clearance on 1986-11-07, under 510(k) number K861435.

Who is the listed applicant for BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE?

The FDA 510(k) record lists The John Bunn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE?

The FDA product code for BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE is CAW.

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Other records listing The John Bunn Co. 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.

K900854JOHN BUNN: MEDIX COMPACT TRAVELLERK883216BUNN MODEL 50 OXYGEN FLOW CONTROLLERK873071BUNN CONCENTRATOR MODEL 2100 SERIESK870094BUNN MODEL 530 ASPIRATORK861199BUNN MODEL 22 OXYGEN FLOW CONTROLLERK862628BUNN MODEL 510 MEDICATION COMPRESSOR

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Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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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