The following data is part of a premarket notification filed by Novamedix Ltd. with the FDA for A-v Impulse System Model 6060.
| Device ID | K953648 |
| 510k Number | K953648 |
| Device Name: | A-V IMPULSE SYSTEM MODEL 6060 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | NOVAMEDIX LTD. C/O POWELL-GOLDSTEIN FRAZ-MURP 1001 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Contact | William H.e. Von Oehsen |
| Correspondent | William H.e. Von Oehsen 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 | 1995-08-04 |
| Decision Date | 1996-02-12 |