NEMIO
System, Imaging, Pulsed Doppler, Ultrasonic
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Nemio.
Pre-market Notification Details
| Device ID | K010631 |
| 510k Number | K010631 |
| Device Name: | NEMIO |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-03-02 |
| Decision Date | 2001-03-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670001635 | K010631 | 000 |
| 04987670001130 | K010631 | 000 |
| 04987670001116 | K010631 | 000 |
Trademark Results [NEMIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEMIO 76455323 2842340 Dead/Cancelled |
Kabushiki Kaisha Toshiba 2002-10-01 |
 NEMIO 76100140 2634072 Live/Registered |
CANON MEDICAL SYSTEMS CORPORATION 2000-08-01 |
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