The following data is part of a premarket notification filed by Aerobiotix, Inc. with the FDA for Aerocure-md.
| Device ID | K203189 |
| 510k Number | K203189 |
| Device Name: | AEROCURE-MD |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | Aerobiotix, Inc. 444 Alexandersville Rd. Miamisburg, OH 45342 |
| Contact | David Kirschman |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-27 |
| Decision Date | 2021-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852348007551 | K203189 | 000 |
| 00852348007773 | K203189 | 000 |