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FDA 510(k)

FLEXTUBES:9, 20, 26

K-Number: K781428 · 1978-09-11

ApplicantBourns Medical Systems, Inc.
Decision Date1978-09-11
Product CodeBYX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXTUBES:9, 20, 26 is the device name listed in this FDA 510(k) record. The listed applicant is Bourns Medical Systems, Inc.. It received FDA 510(k) clearance on 1978-09-11 under 510(k) number K781428. The device is classified under product code BYX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXTUBES:9, 20, 26?

FLEXTUBES:9, 20, 26 is a medical device that received FDA 510(k) clearance on 1978-09-11. The listed applicant is Bourns Medical Systems, Inc.. The 510(k) number is K781428.

When did FLEXTUBES:9, 20, 26 receive FDA 510(k) clearance?

FLEXTUBES:9, 20, 26 received FDA 510(k) clearance on 1978-09-11, under 510(k) number K781428.

Who is the listed applicant for FLEXTUBES:9, 20, 26?

The FDA 510(k) record lists Bourns Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXTUBES:9, 20, 26?

The FDA product code for FLEXTUBES:9, 20, 26 is BYX.

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Other records listing Bourns Medical Systems, 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.

K802118BEAR 2 ADULT VOL. VENTILATORK802051NEWBOURNS INFANT VENTILATORK801697MODEL BP-200 INFANT PRESSURE VENTILATORK791186MODEL BP-2000 TIME-CYCLED VENTILATORK790199VENTILATOR MODEL BV-300 INFANTK781760HUMIDIFIERS, MODEL:LS-420 AND LS-460

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Related Devices (Code: BYX)

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.

K011134OXYGEN SUPPLY TUBING, MODEL 1115Hudson Respiratory Care, Inc.K955656NORTH STATE PLASTICS AEROSOL TEENorth State Plastics, Inc.K943110GAS SAMPLING INTERFACESCoast Medical, Inc.K935835BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIESBusse Hospital Disposables, Inc.K931033MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.K931043MF OHMEDA STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.

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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