AIRZONE PEAK FLOWMETER

K982334 · Clement Clarke Intl., Ltd. · BZH · Jan 14, 1999 · Anesthesiology

Device Facts

• Record ID: K982334
• Device Name: AIRZONE PEAK FLOWMETER
• Applicant: Clement Clarke Intl., Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.

Device Story

AirZone Peak Flowmeter is a handheld device used to measure peak expiratory flow rate (PEFR). Patients with respiratory conditions like asthma, emphysema, or reversible airway obstruction exhale into the device. The device provides a physical measurement of airflow, which the patient or clinician uses to monitor respiratory function and manage disease state. It is intended for use in clinical or home settings.

Indications for Use

Indicated for patients with respiratory conditions including asthma, emphysema, or reversible airway obstruction requiring measurement of peak expiratory flow rate.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Mr. M.J. Wilkinson Clement Clarke International Ltd. Edinburgh Way, Harlow, Essex CM20 2TT ENGLAND

K982334 Re : AirZone Peak Flowmeter Regulatory Class: II (two) Product Code: 73 BZH Dated: October 28, 1998 Received: October 30, 1998

Dear Mr. Wilkinson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. M.J. Wilkinson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix 3 Issue 2

510 (K) Number (if known)

K 982334

Device Name

AirZone Peak Flowmeter

The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.

:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (* 2012 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter Use .........................................................................................................................................................

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K182334

Optional Format 1-2-96

**MW5626a**

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User: TXM: McDonald, Theresa M. (OSM/DID) Note :

K982152 Folder: Document: 510KSUM: 21-SEP-98

Pages : 1 - 4

> Date Requested: Thu Mar 25 10:02:24 1999 Date Printed: Thu Mar 25 10:03:02 1999 Printer: 0K4IMG03