The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for Airzone Peak Flowmeter.
| Device ID | K982334 |
| 510k Number | K982334 |
| Device Name: | AIRZONE PEAK FLOWMETER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Contact | M J Wilkinson |
| Correspondent | M J Wilkinson CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1999-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796699406 | K982334 | 000 |