The following data is part of a premarket notification filed by Med-dyne with the FDA for Patient Cable.
| Device ID | K080112 |
| 510k Number | K080112 |
| Device Name: | PATIENT CABLE |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | MED-DYNE 2775 SOUTH FLOYD ST. Louisville, KY 40209 |
| Contact | E.w. Johnson |
| Correspondent | E.w. Johnson MED-DYNE 2775 SOUTH FLOYD ST. Louisville, KY 40209 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-16 |
| Decision Date | 2008-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817497020622 | K080112 | 000 |
| 00817497021414 | K080112 | 000 |
| 00817497021407 | K080112 | 000 |
| 00817497021391 | K080112 | 000 |
| 00817497021384 | K080112 | 000 |
| 00817497021377 | K080112 | 000 |
| 00817497021360 | K080112 | 000 |
| 00817497021353 | K080112 | 000 |
| 00817497021001 | K080112 | 000 |
| 00817497020998 | K080112 | 000 |
| 00817497020851 | K080112 | 000 |
| 00817497020844 | K080112 | 000 |
| 00868795000212 | K080112 | 000 |
| 00817497021421 | K080112 | 000 |
| 00817497021438 | K080112 | 000 |
| 00817497020615 | K080112 | 000 |
| 00817497020608 | K080112 | 000 |
| 00817497020592 | K080112 | 000 |
| 00817497020585 | K080112 | 000 |
| 00817497020578 | K080112 | 000 |
| 00817497020561 | K080112 | 000 |
| 00817497020554 | K080112 | 000 |
| 00817497020547 | K080112 | 000 |
| 00817497020530 | K080112 | 000 |
| 00817497022992 | K080112 | 000 |
| 00817497021919 | K080112 | 000 |
| 00817497021445 | K080112 | 000 |
| 00868795000205 | K080112 | 000 |