The following data is part of a premarket notification filed by Rashman Corp. with the FDA for Omron, Lumiscope, Labtron, Medi - Source, Baxter.
| Device ID | K955342 |
| 510k Number | K955342 |
| Device Name: | OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | RASHMAN CORP. 2126 BERWICK Inverness, IL 60676 |
| Contact | Bruce Schullo |
| Correspondent | Bruce Schullo RASHMAN CORP. 2126 BERWICK Inverness, IL 60676 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1996-06-17 |