The following data is part of a premarket notification filed by Wireless Medcare, Llc with the FDA for Vivatrak.
Device ID | K101109 |
510k Number | K101109 |
Device Name: | VIVATRAK |
Classification | Monitor, Bed Patient |
Applicant | WIRELESS MEDCARE, LLC 1733 CANTON LANE Marietta, GA 30062 |
Contact | Paul Sumner |
Correspondent | Paul Sumner WIRELESS MEDCARE, LLC 1733 CANTON LANE Marietta, GA 30062 |
Product Code | KMI |
CFR Regulation Number | 880.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-20 |
Decision Date | 2010-07-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIVATRAK 77850211 4100571 Dead/Cancelled |
Wireless MedCARE, LLC 2009-10-16 |