ACCUPEN
Tonometer, Ac-powered
ACCUTOME ULTRASOUND, INC.
The following data is part of a premarket notification filed by Accutome Ultrasound, Inc. with the FDA for Accupen.
Pre-market Notification Details
| Device ID | K083377 |
| 510k Number | K083377 |
| Device Name: | ACCUPEN |
| Classification | Tonometer, Ac-powered |
| Applicant | ACCUTOME ULTRASOUND, INC. 263 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Brian T.s. Barrett |
| Correspondent | Brian T.s. Barrett ACCUTOME ULTRASOUND, INC. 263 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-14 |
| Decision Date | 2009-07-27 |
Trademark Results [ACCUPEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUPEN 85194110 4104129 Dead/Cancelled |
PCCA USA 2010-12-09 |
 ACCUPEN 78955247 not registered Dead/Abandoned |
Owen Mumford Limited 2006-08-18 |
 ACCUPEN 78172616 not registered Dead/Abandoned |
Toshiba America Information Systems, Inc. 2002-10-09 |
 ACCUPEN 76527484 3303065 Live/Registered |
Accutome Ultrasound, Inc. 2003-07-03 |
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