The following data is part of a premarket notification filed by St Jude Medical, Crmd with the FDA for Merlin Psa Patient Cable Ex 3150, Cable Adapter Ex3170, M Adapter Ex3180.
Device ID | K101982 |
510k Number | K101982 |
Device Name: | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 |
Classification | Tester, Pacemaker Electrode Function |
Applicant | ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale, CA 94086 |
Contact | Gina Correa |
Correspondent | Gina Correa ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale, CA 94086 |
Product Code | DTA |
CFR Regulation Number | 870.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-14 |
Decision Date | 2010-12-21 |
Summary: | summary |