Personal Best II with Zone Management System

FDA 510(k) K962924 · Healthscan Products, Inc.

Substantially Equivalent

510(k) numberK962924

Submission

Device name
Personal Best II with Zone Management System
Applicant
Healthscan Products, Inc.
Cedar Grove, NJ, US
Received
July 29, 1996
Decision date
October 25, 1996
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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K232588Aluna 2BZH · Traditional Knox Medical Diagnostics11/25/2024SE
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K222810TD-7301 Peak Flow meterBZH · Traditional Gostar Co., Ltd.12/19/2023SE
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K193311AlunaBZH · Traditional Knox Medical Diagnostics, Inc.03/25/2020SE
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More from Guangzhou Homesun Medical Technology Co., Ltd.

510(k)DeviceDecision
K962929Personal Best IIBZH · Traditional 10/24/1996SE
K962822OptichamberCAF · Traditional 10/17/1996SE
K961077Pep (Positive Expiratory Pressure) Therapy DeviceBWF · Traditional 07/15/1996SE
K933889Personal Best Low RangeBZH · Traditional 09/09/1993SE

Questions and answers

When was Personal Best II with Zone Management System cleared by the FDA?

Personal Best II with Zone Management System (K962924) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 88 days after the submission was received.

What is the product code of K962924?

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