The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for Vm Plus Peak Flowmeter.
| Device ID | K962074 |
| 510k Number | K962074 |
| Device Name: | VM PLUS PEAK FLOWMETER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Contact | Michael J Wilkinson |
| Correspondent | Michael 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 | 1996-05-28 |
| Decision Date | 1997-01-02 |
| Summary: | summary |