The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Oxy/star Low Flow Blender.
| Device ID | K952878 |
| 510k Number | K952878 |
| Device Name: | OXY/STAR LOW FLOW BLENDER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| 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 | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-09-25 |