The following data is part of a premarket notification filed by Mesa Medical, Inc. with the FDA for Model 90dx Multitest Meter.
| Device ID | K882032 |
| 510k Number | K882032 |
| Device Name: | MODEL 90DX MULTITEST METER |
| Classification | Meter, Conductivity, Induction, Remote Type |
| 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 | FLB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1988-08-11 |