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FDA 510(k)

MSI PRESSURE INFUSOR

K-Number: K973843 · 1997-10-29

ApplicantSmith Assoc.
Decision Date1997-10-29
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MSI PRESSURE INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith Assoc.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K973843. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSI PRESSURE INFUSOR?

MSI PRESSURE INFUSOR is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Smith Assoc.. The 510(k) number is K973843.

When did MSI PRESSURE INFUSOR receive FDA 510(k) clearance?

MSI PRESSURE INFUSOR received FDA 510(k) clearance on 1997-10-29, under 510(k) number K973843.

Who is the listed applicant for MSI PRESSURE INFUSOR?

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

What is the FDA product code for MSI PRESSURE INFUSOR?

The FDA product code for MSI PRESSURE INFUSOR is KZD.

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Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, Inc.

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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