SOFTVUE
System, Imaging, Pulsed Echo, Ultrasonic
DELPHINUS MEDICAL TECHNOLOGIES, INC
The following data is part of a premarket notification filed by Delphinus Medical Technologies, Inc with the FDA for Softvue.
Pre-market Notification Details
| Device ID | K123209 |
| 510k Number | K123209 |
| Device Name: | SOFTVUE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
| Contact | Andrea N Wallen |
| Correspondent | Andrea N Wallen DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
Trademark Results [SOFTVUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTVUE 87043815 not registered Live/Pending |
Delphinus Medical Technologies, Inc. 2016-05-19 |
 SOFTVUE 74514735 not registered Dead/Abandoned |
O.S.I. Corporation 1994-04-15 |
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