The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex Ohmeda S/5 Web Viewer And S/5 Pocket Viewer With L-web03 Software.
| Device ID | K033078 |
| 510k Number | K033078 |
| Device Name: | DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA 86 PILGRIM RD. 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 | 2003-09-29 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682106498 | K033078 | 000 |