A-SCAN PLUS CONNECT
System, Imaging, Pulsed Echo, Ultrasonic
ACCUTOME, INC.
The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for A-scan Plus Connect.
Pre-market Notification Details
| Device ID | K123349 |
| 510k Number | K123349 |
| Device Name: | A-SCAN PLUS CONNECT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACCUTOME, INC. 3222 Phoenixville Pike Frazer, PA 19355 |
| Contact | Adam Pickholtz |
| Correspondent | Adam Pickholtz ACCUTOME, INC. 3222 Phoenixville Pike Frazer, PA 19355 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-01-29 |
| Summary: | summary |
Trademark Results [A-SCAN PLUS CONNECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-SCAN PLUS CONNECT 85703862 4471818 Live/Registered |
Accutome Ultrasound, Inc. 2012-08-15 |
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