The following data is part of a premarket notification filed by Dms-service Llc with the FDA for Mypatch.
| Device ID | K131190 |
| 510k Number | K131190 |
| Device Name: | MYPATCH |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | DMS-SERVICE LLC 2800 NEILSON WAY, STE. 1 Santa Monica, CA 90405 |
| Contact | Lynda S Cole |
| Correspondent | Lynda S Cole DMS-SERVICE LLC 2800 NEILSON WAY, STE. 1 Santa Monica, CA 90405 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980020702 | K131190 | 000 |
| 00817980020696 | K131190 | 000 |
| 00817980020689 | K131190 | 000 |
| 00817980020368 | K131190 | 000 |
| 00817980020344 | K131190 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYPATCH 85886397 4486358 Live/Registered |
Cardio Designs And Marketing LLC 2013-03-26 |