Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GALEMED PEAK FLOW METER, MODELS 3751/3752

K-Number: K022124 · 2003-04-03

ApplicantGalemed Corp.
Decision Date2003-04-03
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GALEMED PEAK FLOW METER, MODELS 3751/3752 is the device name listed in this FDA 510(k) record. The listed applicant is Galemed Corp.. It received FDA 510(k) clearance on 2003-04-03 under 510(k) number K022124. 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 GALEMED PEAK FLOW METER, MODELS 3751/3752?

GALEMED PEAK FLOW METER, MODELS 3751/3752 is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Galemed Corp.. The 510(k) number is K022124.

When did GALEMED PEAK FLOW METER, MODELS 3751/3752 receive FDA 510(k) clearance?

GALEMED PEAK FLOW METER, MODELS 3751/3752 received FDA 510(k) clearance on 2003-04-03, under 510(k) number K022124.

Who is the listed applicant for GALEMED PEAK FLOW METER, MODELS 3751/3752?

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

What is the FDA product code for GALEMED PEAK FLOW METER, MODELS 3751/3752?

The FDA product code for GALEMED PEAK FLOW METER, MODELS 3751/3752 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 Galemed Corp. 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.

K122627GIO DIGITAL PRESSURE GUAGESK082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEK072755GALEMED CPAP MASKK021742GALEMED NEB-EASY NEBULIZER

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑