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FDA 510(k)

MAXI-USE O2 DEVICE

K-Number: K861325 · 1986-09-09

ApplicantB & F Medical Products, Inc.
Decision Date1986-09-09
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAXI-USE O2 DEVICE 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 1986-09-09 under 510(k) number K861325. 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 MAXI-USE O2 DEVICE?

MAXI-USE O2 DEVICE is a medical device that received FDA 510(k) clearance on 1986-09-09. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K861325.

When did MAXI-USE O2 DEVICE receive FDA 510(k) clearance?

MAXI-USE O2 DEVICE received FDA 510(k) clearance on 1986-09-09, under 510(k) number K861325.

Who is the listed applicant for MAXI-USE O2 DEVICE?

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 MAXI-USE O2 DEVICE?

The FDA product code for MAXI-USE O2 DEVICE is NFB.

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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 MASKK861054DISPOSABLE RESCUE BREATHING DEVICEK853004PORTABLE OXYGEN UNITK843691PORTABLE OXYGEN UNIT

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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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, 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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