The following data is part of a premarket notification filed by The Metrix Company with the FDA for Metrixcare.
Device ID | K132424 |
510k Number | K132424 |
Device Name: | METRIXCARE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | THE METRIX COMPANY 4400 CHAVENELLE RD. Dubuque, IA 52002 -2655 |
Contact | Nicholas Specht |
Correspondent | Nicholas Specht THE METRIX COMPANY 4400 CHAVENELLE RD. Dubuque, IA 52002 -2655 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-05 |
Decision Date | 2014-02-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50812496010433 | K132424 | 000 |
50812496010372 | K132424 | 000 |
50812496010310 | K132424 | 000 |
50812496010198 | K132424 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
METRIXCARE 77471466 not registered Dead/Abandoned |
The Metrix Company 2008-05-12 |