The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Long Life Padtm.
| Device ID | K120516 |
| 510k Number | K120516 |
| Device Name: | LONG LIFE PADTM |
| Classification | Electrode, Cutaneous |
| Applicant | OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796614324 | K120516 | 000 |
| 00073796614317 | K120516 | 000 |
| 00073796261429 | K120516 | 000 |
| 00073796226145 | K120516 | 000 |