510(k) K925210
- Device
- 90DX MULTITEST METER, MODIFICATION
- Applicant
- MESA MEDICAL, INC.
- 510(k) number
- K925210
- Product code
- FLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-25
- Date received
- 1992-10-07
- Regulation
- 876.5820
- Classification name
- Meter, Conductivity, Induction, Remote Type
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFF ZEPP
- Address
- 3904 Youngfield St. Wheat Ridge CO US 80033 80033
FDA Registration Numbers#
- 2020976
Source Documents#
Other 510(k) Records For Product Code FLB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100237 | DIALYSATE METER, MODEL D-6 | Myron L Company | 2010-04-23 |
| K882032 | MODEL 90DX MULTITEST METER | Mesa Medical, Inc. | 1988-08-11 |
| K830629 | COBE RX METER | Cobe Laboratories, Inc. | 1983-04-06 |
| K821415 | MODEL 90 BC | Western Laboratories Corp. | 1982-05-27 |
| K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE | Renal Systems, Inc. | 1977-02-18 |
Legacy Summary#
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FDA Review#
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