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FDA 510(k)

DRESSING CHANGE KIT

K-Number: K900665 · 1990-05-14

ApplicantHealthdyne Cardiovascular, Inc.
Decision Date1990-05-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DRESSING CHANGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Cardiovascular, Inc.. It received FDA 510(k) clearance on 1990-05-14 under 510(k) number K900665. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DRESSING CHANGE KIT?

DRESSING CHANGE KIT is a medical device that received FDA 510(k) clearance on 1990-05-14. The listed applicant is Healthdyne Cardiovascular, Inc.. The 510(k) number is K900665.

When did DRESSING CHANGE KIT receive FDA 510(k) clearance?

DRESSING CHANGE KIT received FDA 510(k) clearance on 1990-05-14, under 510(k) number K900665.

Who is the listed applicant for DRESSING CHANGE KIT?

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

What is the FDA product code for DRESSING CHANGE KIT?

The FDA product code for DRESSING CHANGE KIT is FXX.

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Other records listing Healthdyne Cardiovascular, Inc. as applicant

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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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