The following data is part of a premarket notification filed by Girgis Scope Llc with the FDA for Girgis Scope Video 200 Double Bladed Laryngoscope (gsv200.dbl).
Device ID | K163412 |
510k Number | K163412 |
Device Name: | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) |
Classification | Laryngoscope, Rigid |
Applicant | Girgis Scope LLC 2 Stonegate Drive Monroe Township, NJ 08831 |
Contact | Madgy S. Girgis |
Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-05 |
Decision Date | 2017-06-22 |
Summary: | summary |