The following data is part of a premarket notification filed by Med Systems, Inc. with the FDA for Electro Flo 6 Airway Clearance System.
| Device ID | K201490 |
| 510k Number | K201490 |
| Device Name: | Electro Flo 6 Airway Clearance System |
| Classification | Percussor, Powered-electric |
| Applicant | Med Systems, Inc. 2631 Ariane Drive San Diego, CA 92117 |
| Contact | Susan B Davis |
| Correspondent | Frederick Cahn BioMedical Strategies 133 Colonial Dr. White River Junction, VT 05001 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2021-02-12 |