The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hem-7320.
| Device ID | K133383 |
| 510k Number | K133383 |
| Device Name: | HEM-7320 |
| 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 | 2014-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10605388044263 | K133383 | 000 |
| 00073796745530 | K133383 | 000 |
| 10073796735040 | K133383 | 000 |
| 10073796267459 | K133383 | 000 |
| 10073796735316 | K133383 | 000 |
| 10073796745315 | K133383 | 000 |
| 10073796267350 | K133383 | 000 |
| 00073796265250 | K133383 | 000 |
| 10073796361720 | K133383 | 000 |
| 00073796267612 | K133383 | 000 |
| 00073796267865 | K133383 | 000 |
| 00073796276041 | K133383 | 000 |
| 00073796278540 | K133383 | 000 |
| 00073796364175 | K133383 | 000 |
| 00073796761349 | K133383 | 000 |
| 00073796761431 | K133383 | 000 |
| 20073796769318 | K133383 | 000 |
| 00073796786342 | K133383 | 000 |
| 10073796252554 | K133383 | 000 |