The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Wright Ventilometer Vm-1.
Device ID | K895953 |
510k Number | K895953 |
Device Name: | WRIGHT VENTILOMETER VM-1 |
Classification | Spirometer, Diagnostic |
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 | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-11 |
Decision Date | 1990-02-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WRIGHT VENTILOMETER VM-1 74237055 1800618 Dead/Cancelled |
Clement Clarke, Inc. 1992-01-13 |