The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hem-7311.
| Device ID | K133379 |
| 510k Number | K133379 |
| Device Name: | HEM-7311 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-04 |
| Decision Date | 2014-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681131895408 | K133379 | 000 |
| 10073796251007 | K133379 | 000 |
| 10073796710023 | K133379 | 000 |
| 10073796267251 | K133379 | 000 |
| 10073796725317 | K133379 | 000 |
| 10073796267206 | K133379 | 000 |
| 00073796100315 | K133379 | 000 |
| 10073796711020 | K133379 | 000 |
| 00073796930004 | K133379 | 000 |
| 10073796272552 | K133379 | 000 |
| 00073796265359 | K133379 | 000 |
| 10073796265455 | K133379 | 000 |
| 00073796920005 | K133379 | 000 |
| 00073796765316 | K133379 | 000 |
| 00073796742348 | K133379 | 000 |
| 00073796710347 | K133379 | 000 |
| 00073796710217 | K133379 | 000 |
| 00073796343996 | K133379 | 000 |
| 00073796343170 | K133379 | 000 |
| 00073796274245 | K133379 | 000 |
| 00073796271046 | K133379 | 000 |
| 10073796271500 | K133379 | 000 |