Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K983643 |
Device Name |
GENESIS BLS |
Applicant |
O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Applicant Contact |
KEVIN BOWDEN |
Correspondent |
O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Correspondent Contact |
KEVIN BOWDEN |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 10/16/1998 |
Decision Date | 10/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|