The following data is part of a premarket notification filed by Lifesync Corporation with the FDA for Lifesync Adapter, Model Ls-302.
Device ID | K071751 |
510k Number | K071751 |
Device Name: | LIFESYNC ADAPTER, MODEL LS-302 |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | LIFESYNC CORPORATION 8282 SHADOWWOOD DRIVE Coral Springs, FL 33071 |
Contact | Diane Sudduth |
Correspondent | Diane Sudduth LIFESYNC CORPORATION 8282 SHADOWWOOD DRIVE Coral Springs, FL 33071 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-28 |
Decision Date | 2007-08-27 |