The following data is part of a premarket notification filed by Intracom Corp. with the FDA for Echolive Family, Models: Zl-1010,zl-2000,zl-2100,zl-3000,zl-4000.
| Device ID | K984405 |
| 510k Number | K984405 |
| Device Name: | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | INTRACOM CORP. 1309 S. MARY AVE. Sunnyvale, CA 94087 |
| Contact | James A Nations |
| Correspondent | James A Nations INTRACOM CORP. 1309 S. MARY AVE. Sunnyvale, CA 94087 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-09 |
| Decision Date | 1999-02-08 |
| Summary: | summary |