The following data is part of a premarket notification filed by Engineered Medical Systems Inc. with the FDA for Endoscopy Oxygen Mask.
| Device ID | K220533 |
| 510k Number | K220533 |
| Device Name: | Endoscopy Oxygen Mask |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Engineered Medical Systems Inc. 2055 Executive Dr Indianapolis, IN 46241 |
| Contact | Tamara Lefevers |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-11-16 |