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 |