The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Critikit Plus In Line Room/ice Temperature Injectate Kit.
| Device ID | K936182 |
| 510k Number | K936182 |
| Device Name: | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT |
| Classification | Probe, Thermodilution |
| Applicant | OHMEDA MEDICAL 1911 WILLIAMS DR. Oxnard, CA 93030 -2629 |
| Contact | Tim R Williams |
| Correspondent | Tim R Williams OHMEDA MEDICAL 1911 WILLIAMS DR. Oxnard, CA 93030 -2629 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450557109 | K936182 | 000 |