The following data is part of a premarket notification filed by Wireless 2000 Rf & Uwb Technologies Ltd. with the FDA for Pam 3000.
| Device ID | K082626 |
| 510k Number | K082626 |
| Device Name: | PAM 3000 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. 2421 ALPHA AVE Burnaby, Bc, CA V5c5l2 |
| Contact | Efraim Gavrilovich |
| Correspondent | Efraim Gavrilovich WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. 2421 ALPHA AVE Burnaby, Bc, CA V5c5l2 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-01-16 |
| Summary: | summary |