Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K014115 |
Device Name |
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
Applicant |
PORTEX, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
TIMOTHY J TALCOTT |
Correspondent |
PORTEX, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
TIMOTHY J TALCOTT |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 12/14/2001 |
Decision Date | 02/27/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|