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FDA 510(k)

HOTMAN

K-Number: K952172 · 1997-06-10

ApplicantHemo Sapiens, Inc.
Decision Date1997-06-10
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOTMAN is the device name listed in this FDA 510(k) record. The listed applicant is Hemo Sapiens, Inc.. It received FDA 510(k) clearance on 1997-06-10 under 510(k) number K952172. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTMAN?

HOTMAN is a medical device that received FDA 510(k) clearance on 1997-06-10. The listed applicant is Hemo Sapiens, Inc.. The 510(k) number is K952172.

When did HOTMAN receive FDA 510(k) clearance?

HOTMAN received FDA 510(k) clearance on 1997-06-10, under 510(k) number K952172.

Who is the listed applicant for HOTMAN?

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

What is the FDA product code for HOTMAN?

The FDA product code for HOTMAN is DSB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hemo Sapiens, 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.

K962128TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

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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