The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Rascal Ii.
| Device ID | K920622 |
| 510k Number | K920622 |
| Device Name: | RASCAL II |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | OHMEDA MEDICAL 4745 WILEY POST WAY, 650 PLAZA 6 Salt Lake City, UT 84116 |
| Contact | Dwight Hibdon |
| Correspondent | Dwight Hibdon OHMEDA MEDICAL 4745 WILEY POST WAY, 650 PLAZA 6 Salt Lake City, UT 84116 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-10-13 |