The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Digital Wrist Blood Pressure Monitor, Model Hem-609n.
| Device ID | K042505 |
| 510k Number | K042505 |
| Device Name: | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Iwao Kojima |
| Correspondent | Iwao Kojima OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-15 |
| Decision Date | 2005-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796832117 | K042505 | 000 |
| 00073796652319 | K042505 | 000 |