The following data is part of a premarket notification filed by Transformair, Llc with the FDA for Transformair Indoor Air Purifier.
| Device ID | K161468 |
| 510k Number | K161468 |
| Device Name: | Transformair Indoor Air Purifier |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | Transformair, LLC 3802 Spectrum Blvd Suite 143 Tampa, FL 33612 |
| Contact | Jaya Rao |
| 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 | 2016-05-27 |
| Decision Date | 2017-02-08 |
| Summary: | summary |