The following data is part of a premarket notification filed by Mesa Medical, Inc. with the FDA for 90dx Multitest Meter, Modification.
Device ID | K925210 |
510k Number | K925210 |
Device Name: | 90DX MULTITEST METER, MODIFICATION |
Classification | Meter, Conductivity, Induction, Remote Type |
Applicant | MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Contact | Jeff Zepp |
Correspondent | Jeff Zepp MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Product Code | FLB |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-07 |
Decision Date | 1994-01-25 |