The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Commander 111, Model Cd300-cd399.
| Device ID | K091821 |
| 510k Number | K091821 |
| Device Name: | COMMANDER 111, MODEL CD300-CD399 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CARDIOCOM LLC 4050 OLSEN MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Contact | Julie Bulver |
| Correspondent | Julie Bulver CARDIOCOM LLC 4050 OLSEN MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2009-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000001957 | K091821 | 000 |
| 00763000286996 | K091821 | 000 |
| 00763000286989 | K091821 | 000 |
| 00763000286972 | K091821 | 000 |