The following data is part of a premarket notification filed by Mobisante, Inc. with the FDA for Mobius Ultrasound Imaging System.
| Device ID | K102153 |
| 510k Number | K102153 |
| Device Name: | MOBIUS ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MOBISANTE, INC. 14035 NE 85TH COURT Redmond, WA 98052 |
| Contact | Sailesh Chutani |
| Correspondent | Sailesh Chutani MOBISANTE, INC. 14035 NE 85TH COURT Redmond, WA 98052 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2011-01-20 |
| Summary: | summary |