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 |