The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Model Pm3030.
| Device ID | K110068 |
| 510k Number | K110068 |
| Device Name: | MODEL PM3030 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796633141 | K110068 | 000 |
| 00073796633035 | K110068 | 000 |
| 00073796330316 | K110068 | 000 |