The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Vmx Mini-log Flowmeter.
Device ID | K914126 |
510k Number | K914126 |
Device Name: | VMX MINI-LOG FLOWMETER |
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 | 1991-09-13 |
Decision Date | 1993-03-05 |