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FDA 510(k)

DISPOSABLE RESCUE BREATHING DEVICE

K-Number: K861054 · 1986-04-09

ApplicantB & F Medical Products, Inc.
Decision Date1986-04-09
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE RESCUE BREATHING 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 1986-04-09 under 510(k) number K861054. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE RESCUE BREATHING DEVICE?

DISPOSABLE RESCUE BREATHING DEVICE is a medical device that received FDA 510(k) clearance on 1986-04-09. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K861054.

When did DISPOSABLE RESCUE BREATHING DEVICE receive FDA 510(k) clearance?

DISPOSABLE RESCUE BREATHING DEVICE received FDA 510(k) clearance on 1986-04-09, under 510(k) number K861054.

Who is the listed applicant for DISPOSABLE RESCUE BREATHING 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 DISPOSABLE RESCUE BREATHING DEVICE?

The FDA product code for DISPOSABLE RESCUE BREATHING DEVICE is CAE.

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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 DEVICEK853004PORTABLE OXYGEN UNITK843691PORTABLE OXYGEN UNIT

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Related Devices (Code: CAE)

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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt MedicalK960240RUSCH OPTOSAFERusch Intl.K950613KEISEIKeisei (Usa) Co., Ltd.

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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