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FDA 510(k)

PORTABLE OXYGEN UNIT

K-Number: K853004 · 1985-08-29

ApplicantB & F Medical Products, Inc.
Decision Date1985-08-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN UNIT is the device name listed in this FDA 510(k) record. The listed applicant is B & F Medical Products, Inc.. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853004. 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 PORTABLE OXYGEN UNIT?

PORTABLE OXYGEN UNIT is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K853004.

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

PORTABLE OXYGEN UNIT received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853004.

Who is the listed applicant for PORTABLE OXYGEN UNIT?

The FDA 510(k) record lists B & F Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE OXYGEN UNIT?

The FDA product code for PORTABLE OXYGEN UNIT is CAW.

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Other records listing B & F Medical Products, Inc. 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.

K942645B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REGK920573CANNULA NASAL OXYGENK913501TRACHEOSTOMY MASKK861325MAXI-USE O2 DEVICEK861054DISPOSABLE RESCUE BREATHING DEVICEK843691PORTABLE OXYGEN UNIT

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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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