The following data is part of a premarket notification filed by Tiger Medical Products with the FDA for Disposable Temporary Pacing Cable.
Device ID | K152947 |
510k Number | K152947 |
Device Name: | Disposable Temporary Pacing Cable |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | TIGER MEDICAL PRODUCTS JAJE PLAZA, SUITE 703, 1717 NORTH SICHUAN ROAD Shanghai, CN 200080 |
Contact | Veronica Lee |
Correspondent | Pamela Papineau DELPHI MEDICAL DEVICE CONSULTING, INC 5 WHITCOMB AVENUE Ayer, MA 01432 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-06 |
Decision Date | 2016-04-05 |
Summary: | summary |