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FDA 510(k)

PACER MODEL 100 INFUSION CONTROLLER

K-Number: K963136 · 1997-10-10

ApplicantHealth Watch, Inc.
Decision Date1997-10-10
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PACER MODEL 100 INFUSION CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Health Watch, Inc.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K963136. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACER MODEL 100 INFUSION CONTROLLER?

PACER MODEL 100 INFUSION CONTROLLER is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Health Watch, Inc.. The 510(k) number is K963136.

When did PACER MODEL 100 INFUSION CONTROLLER receive FDA 510(k) clearance?

PACER MODEL 100 INFUSION CONTROLLER received FDA 510(k) clearance on 1997-10-10, under 510(k) number K963136.

Who is the listed applicant for PACER MODEL 100 INFUSION CONTROLLER?

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

What is the FDA product code for PACER MODEL 100 INFUSION CONTROLLER?

The FDA product code for PACER MODEL 100 INFUSION CONTROLLER is LDR.

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 Health Watch, 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.

K921331CAMBRIDGE PC/GXT STRESS TEST SYSTEM

Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.K934543UNIVERSAL CONTROLLER, MODEL 100Metamed, Inc.

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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