The following data is part of a premarket notification filed by Medical Numerics, Inc. with the FDA for Integrated Stimulus Delivery System Optimum And Premium.
| Device ID | K093336 |
| 510k Number | K093336 |
| Device Name: | INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL NUMERICS, INC. 20410 OBSERVATION DRIVE SUITE 210 Germantown, MD 20876 |
| Contact | Douglas M Tucker |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-03-05 |
| Summary: | summary |