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 |