NUWAV
System, Imaging, Pulsed Echo, Ultrasonic
LABORIE MEDICAL TECHNOLOGIES, CORP
The following data is part of a premarket notification filed by Laborie Medical Technologies, Corp with the FDA for Nuwav.
Pre-market Notification Details
| Device ID | K081781 |
| 510k Number | K081781 |
| Device Name: | NUWAV |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, CORP 400 AVE D, STE 10 Williston, VT 05495 |
| Contact | Barbara Mornet |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-24 |
| Decision Date | 2008-07-09 |
Trademark Results [NUWAV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUWAV 98376541 not registered Live/Pending |
Crawford, Chance A 2024-01-26 |
 NUWAV 88229671 not registered Live/Pending |
Ma, Youjin 2018-12-14 |
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