PAXIAL
System, Imaging, Pulsed Echo, Ultrasonic
BIOPHYSIC MEDICAL, INC.
The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Paxial.
Pre-market Notification Details
| Device ID | K853116 |
| 510k Number | K853116 |
| Device Name: | PAXIAL |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-10-31 |
Trademark Results [PAXIAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAXIAL 73569389 1413217 Dead/Cancelled |
BIOPHYSIC MEDICAL S.A. 1985-11-19 |
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