The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Modification To: Bpcard, Model Z-7000-0700.
| Device ID | K073630 |
| 510k Number | K073630 |
| Device Name: | MODIFICATION TO: BPCARD, MODEL Z-7000-0700 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447 |
| Contact | Mary Kay Jensen |
| Correspondent | Mary Kay Jensen QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-01-11 |
| Summary: | summary |