The following data is part of a premarket notification filed by N.i. Medical, Ltd. with the FDA for Bioimpedance Cardiac Analyzing Measuring System.
| Device ID | K080941 |
| 510k Number | K080941 |
| Device Name: | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | N.I. MEDICAL, LTD. 414 MARYJOE WAY Warrington, PA 18976 |
| Contact | James Collie |
| Correspondent | James Collie N.I. MEDICAL, LTD. 414 MARYJOE WAY Warrington, PA 18976 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2009-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015331005 | K080941 | 000 |