The following data is part of a premarket notification filed by Mesa Medical, Inc. with the FDA for Model 102 Ph Meter.
Device ID | K870811 |
510k Number | K870811 |
Device Name: | MODEL 102 PH METER |
Classification | Ph Meter For Dialysis Hydrogen Ion Concentration |
Applicant | MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Contact | Luke R Schmieder |
Correspondent | Luke R Schmieder MESA MEDICAL, INC. 3904 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Product Code | LRI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-03-24 |