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FDA 510(k)

DISPOSABLE ELBOW ADAPTOR

K-Number: K810620 · 1981-03-20

ApplicantIntec Medical, Inc.
Decision Date1981-03-20
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ELBOW ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1981-03-20 under 510(k) number K810620. 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 DISPOSABLE ELBOW ADAPTOR?

DISPOSABLE ELBOW ADAPTOR is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Intec Medical, Inc.. The 510(k) number is K810620.

When did DISPOSABLE ELBOW ADAPTOR receive FDA 510(k) clearance?

DISPOSABLE ELBOW ADAPTOR received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810620.

Who is the listed applicant for DISPOSABLE ELBOW ADAPTOR?

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

What is the FDA product code for DISPOSABLE ELBOW ADAPTOR?

The FDA product code for DISPOSABLE ELBOW ADAPTOR is BZA.

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Other records listing Intec Medical, Inc. as applicant

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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.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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