The following data is part of a premarket notification filed by Novamedix Ltd. with the FDA for A-v Impulse System.
| Device ID | K914461 |
| 510k Number | K914461 |
| Device Name: | A-V IMPULSE SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | NOVAMEDIX LTD. C/O POWELL-GOLDSTEIN FRAZ-MURP 1001 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Contact | Thomas M Antone |
| Correspondent | Thomas M Antone NOVAMEDIX LTD. C/O POWELL-GOLDSTEIN FRAZ-MURP 1001 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1992-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() A-V IMPULSE SYSTEM 75193078 2229887 Live/Registered |
CARDINAL HEALTH IRELAND UNLIMITED COMPANY 1996-11-01 |
![]() A-V IMPULSE SYSTEM 73822940 1689685 Dead/Cancelled |
NOVAMEDIX LTD. 1989-09-01 |