The following data is part of a premarket notification filed by Lifestream Technologies, Inc. with the FDA for Privalink Software Accessory To The Lifestream Cholesterol Monitor.
Device ID | K993096 |
510k Number | K993096 |
Device Name: | PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | LIFESTREAM TECHNOLOGIES, INC. 51O CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
Contact | Jackson B Connolly |
Correspondent | Jackson B Connolly LIFESTREAM TECHNOLOGIES, INC. 51O CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-28 |
Decision Date | 1999-12-20 |