The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Engstrom Edith Models 500,1000,1500 & 1500f.
| Device ID | K864095 |
| 510k Number | K864095 |
| Device Name: | ENGSTROM EDITH MODELS 500,1000,1500 & 1500F |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1987-02-20 |