The following data is part of a premarket notification filed by Daig Corp. with the FDA for Disposable Patient Cable Model 5807.
Device ID | K801064 |
510k Number | K801064 |
Device Name: | DISPOSABLE PATIENT CABLE MODEL 5807 |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | DAIG CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-06 |
Decision Date | 1980-05-14 |