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FDA 510(k)

ONEFLOW

K-Number: K980951 · 2000-02-25

ApplicantSti Medical
Decision Date2000-02-25
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ONEFLOW is the device name listed in this FDA 510(k) record. The listed applicant is Sti Medical. It received FDA 510(k) clearance on 2000-02-25 under 510(k) number K980951. 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 ONEFLOW?

ONEFLOW is a medical device that received FDA 510(k) clearance on 2000-02-25. The listed applicant is Sti Medical. The 510(k) number is K980951.

When did ONEFLOW receive FDA 510(k) clearance?

ONEFLOW received FDA 510(k) clearance on 2000-02-25, under 510(k) number K980951.

Who is the listed applicant for ONEFLOW?

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

What is the FDA product code for ONEFLOW?

The FDA product code for ONEFLOW is BZH.

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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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