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FDA 510(k)

PERSONAL BEST II

K-Number: K962929 · 1996-10-24

ApplicantHealthscan Products, Inc.
Decision Date1996-10-24
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERSONAL BEST II is the device name listed in this FDA 510(k) record. The listed applicant is Healthscan Products, Inc.. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K962929. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL BEST II?

PERSONAL BEST II is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Healthscan Products, Inc.. The 510(k) number is K962929.

When did PERSONAL BEST II receive FDA 510(k) clearance?

PERSONAL BEST II received FDA 510(k) clearance on 1996-10-24, under 510(k) number K962929.

Who is the listed applicant for PERSONAL BEST II?

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

What is the FDA product code for PERSONAL BEST II?

The FDA product code for PERSONAL BEST II is BZH.

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 Healthscan Products, 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.

K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMK962822OPTICHAMBERK961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEK933889PERSONAL BEST LOW RANGE

Related Devices (Code: BZH)

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.

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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