Who is the manufacturer of THE PEAK?

Multispiro, Inc. filed the 510(k) submission for THE PEAK (K920390).

What is the FDA product code for THE PEAK?

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for THE PEAK?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like THE PEAK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

THE PEAK

K920390 · Multispiro, Inc. · BZH · Sep 11, 1992 · Anesthesiology

Device Facts

Record ID	K920390
Device Name	THE PEAK
Applicant	Multispiro, Inc.
Product Code	BZH · Anesthesiology
Decision Date	Sep 11, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

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THE PEAK

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