FDA 510(k)

PRESSURE INFUSOR

K-Number: K881977 · 1988-07-29

Decision Date1988-07-29

Product CodeKZD

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRESSURE INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1988-07-29 under 510(k) number K881977. 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 PRESSURE INFUSOR?

PRESSURE INFUSOR is a medical device that received FDA 510(k) clearance on 1988-07-29. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K881977.

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

PRESSURE INFUSOR received FDA 510(k) clearance on 1988-07-29, under 510(k) number K881977.

Who is the listed applicant for PRESSURE INFUSOR?

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

What is the FDA product code for PRESSURE INFUSOR?

The FDA product code for PRESSURE INFUSOR is KZD.

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Other records listing Primrose Medical, Inc. as applicant

K884713COLONIC BALLOON DIALATORS K884714BILIARY DIALATOR K884715ACHELASIA BALLOON DIALATOR K884711URETHRAL AND URETERAL BALLOON DILATATORS K884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORS K884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

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Related Devices (Code: KZD)

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.

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.