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FDA 510(k)

ACCESS DIGIWIPE SYSTEM

K-Number: K853141 · 1985-11-18

ApplicantMedtech Products, Inc.
Decision Date1985-11-18
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCESS DIGIWIPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Products, Inc.. It received FDA 510(k) clearance on 1985-11-18 under 510(k) number K853141. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS DIGIWIPE SYSTEM?

ACCESS DIGIWIPE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-18. The listed applicant is Medtech Products, Inc.. The 510(k) number is K853141.

When did ACCESS DIGIWIPE SYSTEM receive FDA 510(k) clearance?

ACCESS DIGIWIPE SYSTEM received FDA 510(k) clearance on 1985-11-18, under 510(k) number K853141.

Who is the listed applicant for ACCESS DIGIWIPE SYSTEM?

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

What is the FDA product code for ACCESS DIGIWIPE SYSTEM?

The FDA product code for ACCESS DIGIWIPE SYSTEM is KHE.

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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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