Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K170663 |
Device Name |
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer |
Applicant |
Foremount Enterprise Co., Ltd. |
No. 17, Alley 15, Lane 5, Shenan St., Shengang Dist., |
Taichung City,
TW
42944
|
|
Applicant Contact |
John Yang |
Correspondent |
MDVentures |
131 Bay Point Dr. NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5915
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/06/2017 |
Decision Date | 05/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|