Device Classification Name |
laryngoscope, rigid
|
510(k) Number |
K163412 |
Device Name |
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) |
Applicant |
Girgis Scope LLC |
2 Stonegate Drive |
Monroe Township,
NJ
08831
|
|
Applicant Contact |
Madgy S. Girgis |
Correspondent |
Smith Associates |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
E. J. Smith |
Regulation Number | 868.5540
|
Classification Product Code |
|
Date Received | 12/05/2016 |
Decision Date | 06/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|