The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Engstrom Erica Ii Respirator.
| Device ID | K862025 |
| 510k Number | K862025 |
| Device Name: | ENGSTROM ERICA II RESPIRATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-06-18 |