The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Electrophysiology Catheter.
Device ID | K012708 |
510k Number | K012708 |
Device Name: | ELECTROPHYSIOLOGY CATHETER |
Classification | Catheter, Recording, Electrode, Reprocessed |
Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Contact | Don Selvey |
Correspondent | Don Selvey ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Product Code | NLH |
CFR Regulation Number | 870.1220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-14 |
Decision Date | 2002-08-13 |
Summary: | summary |