The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Electrode Semi-flotation Catheter By J-lloyd Medical, Inc..
Device ID | K973639 |
510k Number | K973639 |
Device Name: | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. |
Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 West Berlin, NJ 08091 |
Contact | James L Skaggs |
Correspondent | James L Skaggs J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 West Berlin, NJ 08091 |
Product Code | DRF |
CFR Regulation Number | 870.1220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-24 |
Decision Date | 1998-04-20 |
Summary: | summary |