← Product Code [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) · K962074

# VM PLUS PEAK FLOWMETER (K962074)

_Clement Clarke Intl., Ltd. · BZH · Jan 2, 1997 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K962074

## Device Facts

- **Applicant:** Clement Clarke Intl., Ltd.
- **Product Code:** [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH.md)
- **Decision Date:** Jan 2, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1860
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Device Story

VMX MINI-LOG FLOWMETER, VENTILOMETER VM1, and VM PLUS are medical devices used for monitoring respiratory flow/ventilation. Devices provide visual display of battery status to prevent operational failure. Operated in clinical or home settings; intended for respiratory assessment. Compliance with BS EN ISO 60601-1 medical electrical equipment safety standards. Maintenance requires routine sterilization of mouthpieces.

## Clinical Evidence

No clinical data provided; device safety supported by compliance with BS EN ISO 60601-1 standard.

## Technological Characteristics

Medical electrical equipment; battery-powered; visual display for battery status; mouthpiece interface; complies with BS EN ISO 60601-1.

## Regulatory Identification

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

## Reference Devices

- VMX MINI-LOG FLOWMETER
- VENTILOMETER VM1
- VM PLUS

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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{0}

INTERNATIONAL
Clement Clarke
A NAAG-STREIT COMPANY
K962074
APPENDIX 1
JAN -2 1997

# PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY

I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS. I further certify that I am aware of the types of problems to which the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 AND VM PLUS is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS is complete and accurate:

## 1. Safety Problems

a) No safety problems should be experienced during use of the device for its intended purpose, and none have been reported for either the VMX, VM1 or VM PLUS. The device complies fully with International BS EN ISO 60601-1 Standard “MEDICAL ELECTRICAL EQUIPMENT; GENERAL SAFETY REQUIREMENTS”.

b) General Medical Standards of cleanliness should be observed in maintaining the instrument, and the mouthpiece should be routinely sterilised in accordance with the Users Instructions.

## 2. Effectiveness Problems

Low battery power will prevent use of the instrument, but visual indication of this is shown on the instrument display, allowing time for a replacement to be fitted.

- PRINTED NAME OF PERSON REQUIRED TO SUBMIT 510 (K)
M.J. WILKINSON

- SIGNATURE OF PERSON REQUIRED TO SUBMIT 510 (K)

- TITLE OF PERSON SUBMITTING 510 (K)
QUALITY ASSURANCE MANAGER

- NAME OF COMPANY: CLEMENT CLARKE INTERNATIONAL LIMITED

- DATE: 10 May 1996

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K962074](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K962074)

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