The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Accessory For Adult Vol. Ventilator.
| Device ID | K842580 |
| 510k Number | K842580 |
| Device Name: | ACCESSORY FOR ADULT VOL. VENTILATOR |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INFRASONICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-03 |
| Decision Date | 1984-08-24 |