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Personal Best II With Zone Management System

by Healthscan Products, Inc.

510(k) K962924

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962924 Date25 Oct 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZH
Device Class
Class II
Regulation
21 CFR Part 868.1860
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Meter, Peak Flow, Spirometry as defined by its device type and nomenclature. It is designed to measure peak expiratory flow rate and assist in spirometry assessments.

It is supplied as a reusable device, cleared via FDA 510(k) under K962924, classified as Class II with product code BZH, and intended for use in clinical settings under the anesthesiology specialty. No information on sterility, MRI safety, sizes, or storage is provided in the data.

Other devices from Healthscan Products, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM used for?

    It is designed to measure peak expiratory flow rate and assist in spirometry assessments, as defined by its device type nomenclature as a Meter, Peak Flow, Spirometry, intended for use in clinical settings under the anesthesiology specialty.

  • Is the PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM reusable or single-use?

    The device is supplied as a reusable device, meaning it is intended for multiple uses after appropriate cleaning and maintenance, as stated in the device description.

  • How was the PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM cleared for market?

    It was cleared via the FDA 510(k) process under submission number K962924, determined to be substantially equivalent to a predicate device, and classified as Class II with product code BZH.