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FDA 510(k)

GENTLE HEADER

K-Number: K902845 · 1990-12-03

ApplicantEnhanced Perfusion Systems, Inc.
Decision Date1990-12-03
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GENTLE HEADER is the device name listed in this FDA 510(k) record. The listed applicant is Enhanced Perfusion Systems, Inc.. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K902845. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLE HEADER?

GENTLE HEADER is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Enhanced Perfusion Systems, Inc.. The 510(k) number is K902845.

When did GENTLE HEADER receive FDA 510(k) clearance?

GENTLE HEADER received FDA 510(k) clearance on 1990-12-03, under 510(k) number K902845.

Who is the listed applicant for GENTLE HEADER?

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

What is the FDA product code for GENTLE HEADER?

The FDA product code for GENTLE HEADER is DWE.

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Related Devices (Code: DWE)

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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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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