The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intera-sensation Family.
| Device ID | K031815 |
| 510k Number | K031815 |
| Device Name: | INTERA-SENSATION FAMILY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -8431 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410826 | K031815 | 000 |
| 06970564410475 | K031815 | 000 |
| 06970564410468 | K031815 | 000 |
| 06970564410239 | K031815 | 000 |
| 06970564410093 | K031815 | 000 |