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 |