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FDA 510(k)

BETAFLO 2000

K-Number: K862273 · 1986-07-18

ApplicantBetaflo, Inc.
Decision Date1986-07-18
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BETAFLO 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Betaflo, Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K862273. 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 BETAFLO 2000?

BETAFLO 2000 is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Betaflo, Inc.. The 510(k) number is K862273.

When did BETAFLO 2000 receive FDA 510(k) clearance?

BETAFLO 2000 received FDA 510(k) clearance on 1986-07-18, under 510(k) number K862273.

Who is the listed applicant for BETAFLO 2000?

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

What is the FDA product code for BETAFLO 2000?

The FDA product code for BETAFLO 2000 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 Betaflo, 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.

K864789BETAFLO 2000 PIGGYBACK 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 & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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