The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Rascal-ii Respiratory And Anesthetic Gas Monitor.
| Device ID | K944052 |
| 510k Number | K944052 |
| Device Name: | RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | OHMEDA MEDICAL P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Charles Morreale |
| Correspondent | Charles Morreale OHMEDA MEDICAL P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1995-07-07 |