The following data is part of a premarket notification filed by Novel Gmbh with the FDA for Emed-f-system.
| Device ID | K871690 |
| 510k Number | K871690 |
| Device Name: | EMED-F-SYSTEM |
| Classification | Transducer, Miniature Pressure |
| Applicant | NOVEL GMBH BEICHSTRASSE 8 Munich, DE 80802 |
| Contact | Susan Diekrager |
| Correspondent | Susan Diekrager NOVEL GMBH BEICHSTRASSE 8 Munich, DE 80802 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-05-15 |