The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Cardiocom Commander Iii.
Device ID | K053303 |
510k Number | K053303 |
Device Name: | CARDIOCOM COMMANDER III |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | CARDIOCOM LLC PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-11-28 |
Decision Date | 2005-12-30 |
Summary: | summary |