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FDA 510(k)

A P HARNESS

K-Number: K981860 · 1999-06-03

ApplicantParaworks Enterprise, Ltd.
Decision Date1999-06-03
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

A P HARNESS is the device name listed in this FDA 510(k) record. The listed applicant is Paraworks Enterprise, Ltd.. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K981860. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A P HARNESS?

A P HARNESS is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Paraworks Enterprise, Ltd.. The 510(k) number is K981860.

When did A P HARNESS receive FDA 510(k) clearance?

A P HARNESS received FDA 510(k) clearance on 1999-06-03, under 510(k) number K981860.

Who is the listed applicant for A P HARNESS?

The FDA 510(k) record lists Paraworks Enterprise, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A P HARNESS?

The FDA product code for A P HARNESS is KMK.

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Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, Inc.K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILETnt Moborg Intl. , Ltd.

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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