The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Hi Flex D-700 Modular Bubble Oxygena-.
| Device ID | K830639 |
| 510k Number | K830639 |
| Device Name: | HI FLEX D-700 MODULAR BUBBLE OXYGENA- |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-01 |
| Decision Date | 1983-05-25 |