The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Adult Ventilator.
| Device ID | K943106 |
| 510k Number | K943106 |
| Device Name: | ADULT VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | INFRASONICS CORP. 3911 SORRENTO VALLEY BLVD. San Diego, CA 92121 -1402 |
| Contact | Jim Hitchin |
| Correspondent | Jim Hitchin INFRASONICS CORP. 3911 SORRENTO VALLEY BLVD. San Diego, CA 92121 -1402 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1995-12-28 |