The following data is part of a premarket notification filed by Aerus Medical Llc with the FDA for Aerus Medical Guardian,model F170a.
| Device ID | K201220 |
| 510k Number | K201220 |
| Device Name: | Aerus Medical Guardian,model F170A |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | Aerus Medical LLC 14841 Dallas Parkway, Suite 500, The Aberdeen Bldg. Dallas, TX 75254 |
| Contact | Andrew Eide |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-05-06 |
| Decision Date | 2020-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006514808 | K201220 | 000 |
| 00860006810108 | K201220 | 000 |