The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Model 105 Ventilator, Modification.
| Device ID | K922477 |
| 510k Number | K922477 |
| Device Name: | MODEL 105 VENTILATOR, MODIFICATION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego, CA 92121 |
| Contact | Jim Hitchin |
| Correspondent | Jim Hitchin INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego, CA 92121 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-08-24 |