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FDA 510(k)

NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR

K-Number: K952824 · 1995-07-20

ApplicantIntertex Medical, Inc.
Decision Date1995-07-20
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Intertex Medical, Inc.. It received FDA 510(k) clearance on 1995-07-20 under 510(k) number K952824. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR?

NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Intertex Medical, Inc.. The 510(k) number is K952824.

When did NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR receive FDA 510(k) clearance?

NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR received FDA 510(k) clearance on 1995-07-20, under 510(k) number K952824.

Who is the listed applicant for NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR?

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

What is the FDA product code for NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR?

The FDA product code for NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR is BZA.

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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Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, Inc.K944532PRIMA, INC. VENTILATOR HOSESPrima, 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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