510(k) K770263
- Device
- DIALYSATE METER RS-2100A, CIRCUIT CHANGE
- Applicant
- Renal Systems, Inc.
- 510(k) number
- K770263
- Product code
- FLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-18
- Date received
- 1977-02-11
- Regulation
- 876.5820
- Classification name
- Meter, Conductivity, Induction, Remote Type
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2020976
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K925210 | 90DX MULTITEST METER, MODIFICATION | Mesa Medical, Inc. | 1994-01-25 |
| 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 |