The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Mini Wright Lr Afs.
| Device ID | K952713 |
| 510k Number | K952713 |
| Device Name: | MINI WRIGHT LR AFS |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Contact | Michael J Wilkinson |
| Correspondent | Michael J Wilkinson CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1996-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607499991255 | K952713 | 000 |
| 00607411001277 | K952713 | 000 |
| 00607411001260 | K952713 | 000 |
| 05023323040503 | K952713 | 000 |
| 05023323001474 | K952713 | 000 |
| 05023323001139 | K952713 | 000 |
| 05023323000941 | K952713 | 000 |