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FDA 510(k)

PRESSURE INFUSION DEVICE

K-Number: K781037 · 1978-09-14

ApplicantHinck Medical, Inc.
Decision Date1978-09-14
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hinck Medical, Inc.. It received FDA 510(k) clearance on 1978-09-14 under 510(k) number K781037. 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 INFUSION DEVICE?

PRESSURE INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1978-09-14. The listed applicant is Hinck Medical, Inc.. The 510(k) number is K781037.

When did PRESSURE INFUSION DEVICE receive FDA 510(k) clearance?

PRESSURE INFUSION DEVICE received FDA 510(k) clearance on 1978-09-14, under 510(k) number K781037.

Who is the listed applicant for PRESSURE INFUSION DEVICE?

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

What is the FDA product code for PRESSURE INFUSION DEVICE?

The FDA product code for PRESSURE INFUSION DEVICE is KZD.

Related Clinical Trials

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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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.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

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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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