The following data is part of a premarket notification filed by Diamond Electro-tech, Inc. with the FDA for Gem-6, With Components.
| Device ID | K854357 |
| 510k Number | K854357 |
| Device Name: | GEM-6, WITH COMPONENTS |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | DIAMOND ELECTRO-TECH, INC. 1230 EISENHOWER PLACE Ann Arbor, MI 48104 |
| Contact | Steven Enzer |
| Correspondent | Steven Enzer DIAMOND ELECTRO-TECH, INC. 1230 EISENHOWER PLACE Ann Arbor, MI 48104 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1986-01-08 |