The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Genie, Model Ch-200.
| Device ID | K070633 |
| 510k Number | K070633 |
| Device Name: | GENIE, MODEL CH-200 |
| Classification | Syringe, Piston |
| Applicant | ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Contact | Tracy Best |
| Correspondent | Tracy Best ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-07 |
| Decision Date | 2007-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709035826 | K070633 | 000 |
| 10887709057118 | K070633 | 000 |
| 10887709062457 | K070633 | 000 |