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FDA 510(k)

LEUNOMED RFB 5000

K-Number: K881164 · 1989-04-24

ApplicantHemodynamics, Inc.
Decision Date1989-04-24
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEUNOMED RFB 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Hemodynamics, Inc.. It received FDA 510(k) clearance on 1989-04-24 under 510(k) number K881164. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEUNOMED RFB 5000?

LEUNOMED RFB 5000 is a medical device that received FDA 510(k) clearance on 1989-04-24. The listed applicant is Hemodynamics, Inc.. The 510(k) number is K881164.

When did LEUNOMED RFB 5000 receive FDA 510(k) clearance?

LEUNOMED RFB 5000 received FDA 510(k) clearance on 1989-04-24, under 510(k) number K881164.

Who is the listed applicant for LEUNOMED RFB 5000?

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

What is the FDA product code for LEUNOMED RFB 5000?

The FDA product code for LEUNOMED RFB 5000 is HCC.

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 Hemodynamics, 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.

K852378LIGHT REFLECTION RHEOGRAPHY

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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