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FDA 510(k)

INFUSABLE

K-Number: K911216 · 1991-07-22

ApplicantBiomedical Dynamics, Inc.
Decision Date1991-07-22
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Dynamics, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K911216. 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 INFUSABLE?

INFUSABLE is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Biomedical Dynamics, Inc.. The 510(k) number is K911216.

When did INFUSABLE receive FDA 510(k) clearance?

INFUSABLE received FDA 510(k) clearance on 1991-07-22, under 510(k) number K911216.

Who is the listed applicant for INFUSABLE?

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

What is the FDA product code for INFUSABLE?

The FDA product code for INFUSABLE 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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Other records listing Biomedical Dynamics, Inc. as applicant

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.

K915074IRRIGATOR/ASPIRATOR PROBEK913751PRESSURE INFUSERK911213CUFFABLEK911324IRRIGATION/ASPIRATION TUBING SETK904376ANEROID BLOOD PRESSURE GAUGEK890268PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION

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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

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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