The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Electrode Switchbox, Model 11-081002.
Device ID | K982835 |
510k Number | K982835 |
Device Name: | ELECTRODE SWITCHBOX, MODEL 11-081002 |
Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Applicant | CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
Contact | Jack P Douglas |
Correspondent | Jack P Douglas CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
Product Code | DRF |
CFR Regulation Number | 870.1220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-12 |
Decision Date | 1998-10-29 |
Summary: | summary |