B-SCAN PLUS
System, Imaging, Pulsed Echo, Ultrasonic
ACCUTOME ULTRASOUND, INC.
The following data is part of a premarket notification filed by Accutome Ultrasound, Inc. with the FDA for B-scan Plus.
Pre-market Notification Details
| Device ID | K070943 |
| 510k Number | K070943 |
| Device Name: | B-SCAN PLUS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACCUTOME ULTRASOUND, INC. 263 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Jeffrey Wright |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-04 |
| Decision Date | 2007-04-19 |
| Summary: | summary |
Trademark Results [B-SCAN PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 B-SCAN PLUS 85755942 4332074 Live/Registered |
Accutome Ultrasound, Inc. 2012-10-17 |
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