The following data is part of a premarket notification filed by Airsonett, Ab with the FDA for Airsonett Air-4.
| Device ID | K130702 |
| 510k Number | K130702 |
| Device Name: | AIRSONETT AIR-4 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AIRSONETT, AB 435 RICE CREEK TERRACE NE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy AIRSONETT, AB 435 RICE CREEK TERRACE NE Fridley, MN 55432 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-15 |
| Decision Date | 2013-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350128750022 | K130702 | 000 |
| 07350128750015 | K130702 | 000 |