Device Classification Name |
monitor, airway pressure (includes gauge and/or alarm)
|
510(k) Number |
K201666 |
Device Name |
SINGLE USE MANOMETER |
Applicant |
Flexicare Medical Limited |
Cynon Valley Business Park |
Mountain Ash,
GB
cf45 4er
|
|
Applicant Contact |
Joel Biddle |
Correspondent |
Flexicare Medical Limited |
Cynon Valley Business Park |
Mountain Ash,
GB
cf45 4er
|
|
Correspondent Contact |
Joel Biddle |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 06/19/2020 |
Decision Date | 11/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|