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FDA 510(k)

TRUEZONE PEAK FLOW METER

K-Number: K023097 · 2003-03-07

ApplicantMonaghan Medical Corp.
Decision Date2003-03-07
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRUEZONE PEAK FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K023097. 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 TRUEZONE PEAK FLOW METER?

TRUEZONE PEAK FLOW METER is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K023097.

When did TRUEZONE PEAK FLOW METER receive FDA 510(k) clearance?

TRUEZONE PEAK FLOW METER received FDA 510(k) clearance on 2003-03-07, under 510(k) number K023097.

Who is the listed applicant for TRUEZONE PEAK FLOW METER?

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

What is the FDA product code for TRUEZONE PEAK FLOW METER?

The FDA product code for TRUEZONE PEAK FLOW METER is BZH.

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Other records listing Monaghan Medical 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.

K123945STRIVE DUAL ZONE PEAK FLOW METERK031514MODIFICATION TO TRUPEAK PEAK FLOW METERK012939AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBERK991212MODIFICATION TO TRUZONE PEAK FLOW METERK964130AEROGEAR ASTHMA ACTION KITK963089TRUZONE PEAK FLOW METER

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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.

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