The following data is part of a premarket notification filed by Network Concepts, Inc. with the FDA for Univision Echocardiology System.
| Device ID | K964803 |
| 510k Number | K964803 |
| Device Name: | UNIVISION ECHOCARDIOLOGY SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | NETWORK CONCEPTS, INC. 2135 W. GREENVIEW DR. Middleton, WI 53562 |
| Contact | Larry Sieb |
| Correspondent | Larry Sieb NETWORK CONCEPTS, INC. 2135 W. GREENVIEW DR. Middleton, WI 53562 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-02-11 |
| Summary: | summary |