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FDA 510(k)

MODIFIED EXTERNAL PAD

K-Number: K891000 · 1989-05-19

ApplicantInstromedix, Inc.
Decision Date1989-05-19
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED EXTERNAL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1989-05-19 under 510(k) number K891000. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED EXTERNAL PAD?

MODIFIED EXTERNAL PAD is a medical device that received FDA 510(k) clearance on 1989-05-19. The listed applicant is Instromedix, Inc.. The 510(k) number is K891000.

When did MODIFIED EXTERNAL PAD receive FDA 510(k) clearance?

MODIFIED EXTERNAL PAD received FDA 510(k) clearance on 1989-05-19, under 510(k) number K891000.

Who is the listed applicant for MODIFIED EXTERNAL PAD?

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

What is the FDA product code for MODIFIED EXTERNAL PAD?

The FDA product code for MODIFIED EXTERNAL PAD is DWS.

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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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