The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Ultra Compact Wrist Blood Pressure Monitor With Intellisense, Model Hem-630.
| Device ID | K001671 |
| 510k Number | K001671 |
| Device Name: | ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Osamu Shirasaki |
| Correspondent | Osamu Shirasaki OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-01 |
| Decision Date | 2000-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796032203 | K001671 | 000 |