The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Adapter Cable.
Device ID | K050884 |
510k Number | K050884 |
Device Name: | ADAPTER CABLE |
Classification | Tester, Pacemaker Electrode Function |
Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
Contact | Don Rosvold |
Correspondent | Don Rosvold REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
Product Code | DTA |
CFR Regulation Number | 870.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-07 |
Decision Date | 2005-05-19 |
Summary: | summary |