The following data is part of a premarket notification filed by American Bentley with the FDA for Holder For Bos-2s Infant Bubble Oxygena-.
| Device ID | K830167 |
| 510k Number | K830167 |
| Device Name: | HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-03-11 |