The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Web Viewer, Pocket Viewer And Cellular Viewer With L- Web05 Software.
| Device ID | K061994 |
| 510k Number | K061994 |
| Device Name: | WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-14 |
| Decision Date | 2006-08-11 |
| Summary: | summary |