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FDA 510(k)

IMPERVIOUS ISOLATION SHOE COVERS

K-Number: K923187 · 1993-01-29

ApplicantDynatech Medical Products
Decision Date1993-01-29
Product CodeFXW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPERVIOUS ISOLATION SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Medical Products. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K923187. The device is classified under product code FXW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPERVIOUS ISOLATION SHOE COVERS?

IMPERVIOUS ISOLATION SHOE COVERS is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is Dynatech Medical Products. The 510(k) number is K923187.

When did IMPERVIOUS ISOLATION SHOE COVERS receive FDA 510(k) clearance?

IMPERVIOUS ISOLATION SHOE COVERS received FDA 510(k) clearance on 1993-01-29, under 510(k) number K923187.

Who is the listed applicant for IMPERVIOUS ISOLATION SHOE COVERS?

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

What is the FDA product code for IMPERVIOUS ISOLATION SHOE COVERS?

The FDA product code for IMPERVIOUS ISOLATION SHOE COVERS is FXW.

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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Other records listing Dynatech Medical Products as applicant

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.

K923188DYNASTY IMPERVIOUS ISOLATION J-SUITK922234DYNASTY ISOLATION GOWNK893520DR. BOO LATEX EXAMINATION GLOVESK770730PUMP, INFUSION, DYNATECH/HANDLEY

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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