The following data is part of a premarket notification filed by Merit Cables Incorporated with the FDA for Variouspatient Monitoring Cable.
Device ID | K942321 |
510k Number | K942321 |
Device Name: | VARIOUSPATIENT MONITORING CABLE |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | MERIT CABLES INCORPORATED 3199 AIRPORT LOOP DR. Costa Mesa, CA 92626 |
Contact | Ronald L Ballard |
Correspondent | Ronald L Ballard MERIT CABLES INCORPORATED 3199 AIRPORT LOOP DR. Costa Mesa, CA 92626 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-13 |
Decision Date | 1994-11-04 |