The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Iqvitals And Iqvitals System.
| Device ID | K100913 |
| 510k Number | K100913 |
| Device Name: | IQVITALS AND IQVITALS SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BRENTWOOD MEDICAL TECHNOLOGY CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland BRENTWOOD MEDICAL TECHNOLOGY CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-05-26 |
| Summary: | summary |