The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Co2mbiled.
| Device ID | K201096 |
| 510k Number | K201096 |
| Device Name: | CO2mbiLED |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Product Code | FCX |
| Subsequent Product Code | FEQ |
| Subsequent Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-24 |
| Decision Date | 2020-06-23 |