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FDA 510(k)

BREATHING CIRCUIT, DISPOSABLE

K-Number: K790115 · 1979-03-16

ApplicantH.B. Laboratories, Inc.
Decision Date1979-03-16
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHING CIRCUIT, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is H.B. Laboratories, Inc.. It received FDA 510(k) clearance on 1979-03-16 under 510(k) number K790115. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHING CIRCUIT, DISPOSABLE?

BREATHING CIRCUIT, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1979-03-16. The listed applicant is H.B. Laboratories, Inc.. The 510(k) number is K790115.

When did BREATHING CIRCUIT, DISPOSABLE receive FDA 510(k) clearance?

BREATHING CIRCUIT, DISPOSABLE received FDA 510(k) clearance on 1979-03-16, under 510(k) number K790115.

Who is the listed applicant for BREATHING CIRCUIT, DISPOSABLE?

The FDA 510(k) record lists H.B. Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATHING CIRCUIT, DISPOSABLE?

The FDA product code for BREATHING CIRCUIT, DISPOSABLE is CAI.

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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