The following data is part of a premarket notification filed by Siemens Medical Solutions Health Services Corporat with the FDA for Smdie Device Interfacing System.
| Device ID | K061590 |
| 510k Number | K061590 |
| Device Name: | SMDIE DEVICE INTERFACING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT 2454 MCMULLEN BOOTH ROAD SUITE 427 Clearwater, FL 33759 |
| Contact | Ian Gordon |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853023006029 | K061590 | 000 |