Product code DRI
- Device name
- Monitor, Line Isolation
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.2620
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Datex Division Instrumentarium Corp. | 1990-07-06 |
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Datex Division Instrumentarium Corp. | 1990-07-06 |
| K822316 | HEART MONITOR BRACELET ALARM | Hmba | 1982-09-21 |
| K802326 | PRESSURE MONITORING LINES | Stanco Medical, Inc. | 1980-10-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H965806412420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965807052020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806428420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806427220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806426020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806424820 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806423620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806422420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806421220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806419620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806418420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806417220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806416020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806414820 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806413620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806210620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806411220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806410620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806227220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806224820 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806223620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806222420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806221220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806220620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806217220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806216020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806214820 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806213620 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806212420 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H965806211220 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |