The following data is part of a premarket notification filed by Biometrix Ltd. with the FDA for Telepulse.
| Device ID | K925040 |
| 510k Number | K925040 |
| Device Name: | TELEPULSE |
| Classification | Plethysmograph, Volume |
| Applicant | BIOMETRIX LTD. 2 SOUND VIEW DR. SUITE 100 Greenwich, CT 06830 |
| Contact | Manfred Asrican |
| Correspondent | Manfred Asrican BIOMETRIX LTD. 2 SOUND VIEW DR. SUITE 100 Greenwich, CT 06830 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-05 |
| Decision Date | 1993-08-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TELEPULSE 86447636 not registered Dead/Abandoned |
Teledrift Company 2014-11-07 |
![]() TELEPULSE 75233711 2129002 Dead/Cancelled |
Asrican, Manfred 1997-01-30 |
![]() TELEPULSE 72032548 0692790 Dead/Cancelled |
SHAND AND JURS CO. 1957-06-24 |