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FDA 510(k)

Safey Peak Flow Meter

K-Number: K200832 · 2020-07-30

ApplicantSafey Medical Devices Pvt, Ltd.
Decision Date2020-07-30
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Safey Peak Flow Meter is the device name listed in this FDA 510(k) record. The listed applicant is Safey Medical Devices Pvt, Ltd.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K200832. 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 Safey Peak Flow Meter?

Safey Peak Flow Meter is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Safey Medical Devices Pvt, Ltd.. The 510(k) number is K200832.

When did Safey Peak Flow Meter receive FDA 510(k) clearance?

Safey Peak Flow Meter received FDA 510(k) clearance on 2020-07-30, under 510(k) number K200832.

Who is the listed applicant for Safey Peak Flow Meter?

The FDA 510(k) record lists Safey Medical Devices Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safey Peak Flow Meter?

The FDA product code for Safey Peak Flow Meter is BZH.

Other records listing Safey Medical Devices Pvt, Ltd. 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.

K201002Safey Pocket Spirometer

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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