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FDA 510(k)

ACU-PATCH

K-Number: K842946 · 1984-12-07

ApplicantAcutek
Decision Date1984-12-07
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACU-PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Acutek. It received FDA 510(k) clearance on 1984-12-07 under 510(k) number K842946. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-PATCH?

ACU-PATCH is a medical device that received FDA 510(k) clearance on 1984-12-07. The listed applicant is Acutek. The 510(k) number is K842946.

When did ACU-PATCH receive FDA 510(k) clearance?

ACU-PATCH received FDA 510(k) clearance on 1984-12-07, under 510(k) number K842946.

Who is the listed applicant for ACU-PATCH?

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

What is the FDA product code for ACU-PATCH?

The FDA product code for ACU-PATCH is KGX.

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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