The following data is part of a premarket notification filed by Carematix Inc. with the FDA for Blip Model Bp-700wf.
| Device ID | K123020 |
| 510k Number | K123020 |
| Device Name: | BLIP MODEL BP-700WF |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CAREMATIX INC. 209 W. JACKSON BLVD. SUITE 800 Chicago, IL 60606 |
| Contact | Sukhwant Khanuja |
| Correspondent | Sukhwant Khanuja CAREMATIX INC. 209 W. JACKSON BLVD. SUITE 800 Chicago, IL 60606 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858393004009 | K123020 | 000 |