UBM PLUS
System, Imaging, Pulsed Doppler, Ultrasonic
ACCUTOME, INC.
The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Ubm Plus.
Pre-market Notification Details
| Device ID | K103471 |
| 510k Number | K103471 |
| Device Name: | UBM PLUS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
| Contact | Brian T.s. Barrett |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-03-14 |
| Summary: | summary |
Trademark Results [UBM PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UBM PLUS 85755944 4332075 Live/Registered |
Accutome Ultrasound, Inc. 2012-10-17 |
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