The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for Mini-wright Digital, Model 3120001.
| Device ID | K053156 |
| 510k Number | K053156 |
| Device Name: | MINI-WRIGHT DIGITAL, MODEL 3120001 |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, Essex, GB Cm20 2tt |
| Contact | Philip Hallybone |
| Correspondent | Philip Hallybone CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, Essex, 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 | 2005-11-14 |
| Decision Date | 2006-01-31 |
| Summary: | summary |