The following data is part of a premarket notification filed by Monagan Ent., Inc. with the FDA for Second Wind Air Purifier.
| Device ID | K980745 |
| 510k Number | K980745 |
| Device Name: | SECOND WIND AIR PURIFIER |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | MONAGAN ENT., INC. 14247 RIDGE RD. Albion, NY 14411 |
| Contact | Gerald C Monagan |
| Correspondent | Gerald C Monagan MONAGAN ENT., INC. 14247 RIDGE RD. Albion, NY 14411 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-26 |
| Decision Date | 1999-04-02 |