The following data is part of a premarket notification filed by Affinity Medical Technologies, Llc. with the FDA for Affinity Medical Patient Cable System.
| Device ID | K980806 |
| 510k Number | K980806 |
| Device Name: | AFFINITY MEDICAL PATIENT CABLE SYSTEM |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | AFFINITY MEDICAL TECHNOLOGIES, LLC. 17332 VON KARMAN AVE., #115 Irvine, CA 92614 |
| Contact | Mary F Phillipp |
| Correspondent | Mary F Phillipp AFFINITY MEDICAL TECHNOLOGIES, LLC. 17332 VON KARMAN AVE., #115 Irvine, CA 92614 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-03-25 |
| Summary: | summary |