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FDA 510(k)

BOTTLE BREATHING DEVICE

K-Number: K780558 · 1978-05-26

ApplicantB & F Medical Products, Inc.
Decision Date1978-05-26
Product CodeBYO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BOTTLE 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 1978-05-26 under 510(k) number K780558. The device is classified under product code BYO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOTTLE BREATHING DEVICE?

BOTTLE BREATHING DEVICE is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K780558.

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

BOTTLE BREATHING DEVICE received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780558.

Who is the listed applicant for BOTTLE 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 BOTTLE BREATHING DEVICE?

The FDA product code for BOTTLE BREATHING DEVICE is BYO.

Related Clinical Trials

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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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 DEVICEK853004PORTABLE OXYGEN UNIT

View all 18 devices →

Related Devices (Code: BYO)

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.

K924541EPIDURAL MINIPACKConcord/PortexK913527HYPERFREEKist Intl.K7804072C7125 BLOW BOTTLETravenol Laboratories, S.A.

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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