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FDA 510(k)

PEAK FLOW METER

K-Number: K970507 · 1997-06-13

ApplicantIntl. Medical, Inc.
Decision Date1997-06-13
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEAK FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K970507. 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 PEAK FLOW METER?

PEAK FLOW METER is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Intl. Medical, Inc.. The 510(k) number is K970507.

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

PEAK FLOW METER received FDA 510(k) clearance on 1997-06-13, under 510(k) number K970507.

Who is the listed applicant for PEAK FLOW METER?

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

What is the FDA product code for PEAK FLOW METER?

The FDA product code for PEAK FLOW METER is BZH.

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Other records listing Intl. Medical, 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.

K943078HOT BIOPSY FORCEPSK940370AMERICAN CATHETER E.R.C.P. CANNULAK940335AMERICAN CATHETER POLY-SNAREK942068AMERICAN CATHETER SPHINCTEROTOMEK930410DURHAM; LUER LOCK EXTENSION SETK930406DURHAM; MIN BORE LUER LOCK EXTENSION SET

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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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