The following data is part of a premarket notification filed by Bar-dix, Inc. with the FDA for Oxygen Delivery Measuring Device.
| Device ID | K851288 |
| 510k Number | K851288 |
| Device Name: | OXYGEN DELIVERY MEASURING DEVICE |
| Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
| Applicant | BAR-DIX, INC. RURAL ROUTE BOX 65 Frazee, MN 56544 |
| Contact | Robert J Herdzina |
| Correspondent | Robert J Herdzina BAR-DIX, INC. RURAL ROUTE BOX 65 Frazee, MN 56544 |
| Product Code | CAX |
| CFR Regulation Number | 868.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-09-03 |