The following data is part of a premarket notification filed by Dms-service Llc with the FDA for Mypatch-s.
| Device ID | K160704 |
| 510k Number | K160704 |
| Device Name: | MyPatch-s |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | DMS-SERVICE LLC 11845 W. OLYMPIC BLVD STE 880W Los Angeles, CA 90064 |
| Contact | Lynda Cole |
| Correspondent | Lynda Cole DMS-SERVICE LLC 11845 W. OLYMPIC BLVD STE 880W Los Angeles, CA 90064 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-14 |
| Decision Date | 2016-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857522005019 | K160704 | 000 |