Peak Flow Monitor

FDA 510(k) K915059 · Spirometrics, Inc.

Substantially Equivalent

510(k) numberK915059

Submission

Device name
Peak Flow Monitor
Applicant
Spirometrics, Inc.
Auburn, ME, US
Received
November 8, 1991
Decision date
July 27, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZH – Meter, Peak Flow, Spirometry
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1860
Specialty
Anesthesiology

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K241338Peak Flow MeterBZH · Traditional Chongqing Moffy Innovation Technology Co., Ltd.12/31/2024SE
K232588Aluna 2BZH · Traditional Knox Medical Diagnostics11/25/2024SE
K230423Electronic Peak Flow MeterBZH · Traditional Taian Dalu Medical Instrument Co., Ltd.02/23/2024SE
K222810TD-7301 Peak Flow meterBZH · Traditional Gostar Co., Ltd.12/19/2023SE
K203196Peak flow meterBZH · Traditional Shanghai Sonmol Medical Equipment Co., Ltd.05/26/2021SE
K200832Safey Peak Flow MeterBZH · Traditional Safey Medical Devices Pvt, Ltd.07/30/2020SE
K193311AlunaBZH · Traditional Knox Medical Diagnostics, Inc.03/25/2020SE
K191239Smart Peak Flow MeterBZH · Traditional Guangzhou Homesun Medical Technology Co., Ltd.12/06/2019SE

More from Guangzhou Homesun Medical Technology Co., Ltd.

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K911358Cmd/Dlco Diagnostic SpirometerBTY · Traditional 07/22/1991SE
K900322CO/CMD-1CCJ · Traditional 04/30/1990SE
K901057Spirometrics Model 2600 Miro SpirometerBZG · Traditional 04/03/1990SE
K900673Serial FlowBZG · Traditional 04/03/1990SE
K884464Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional 01/19/1989SE
K884465Spirometrics Model 2141 Spiro-Filter(Tm)CAH · Traditional 11/09/1988SE
K863953Spirometrics Model 2500 Flowmate(Tm)BZM · Traditional 01/15/1987SE
K850045Spirometrics 2453 & Smi IIIBTY · Traditional 02/14/1985SE
K844333Spirometrics 2451 & Smi IBZG · Traditional 11/20/1984SE
K831497Spirometrics Breon 2400 & Smi 2400BZG · Traditional 06/24/1983SE

Questions and answers

When was Peak Flow Monitor cleared by the FDA?

Peak Flow Monitor (K915059) received a 510(k) decision of Substantially Equivalent on July 27, 1992, 262 days after the submission was received.

What is the product code of K915059?

The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.