The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Intera Family.
| Device ID | K030520 |
| 510k Number | K030520 |
| Device Name: | INTERA FAMILY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-06 |
| Summary: | summary |