The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for He-30 Gold.
| Device ID | K931967 |
| 510k Number | K931967 |
| Device Name: | HE-30 GOLD |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Contact | Paul J Zalesky |
| Correspondent | Paul J Zalesky BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-21 |
| Decision Date | 1993-07-13 |