The following data is part of a premarket notification filed by Albion Instruments with the FDA for Rascal Ii Respiratory And Anesthetic Gas Monitor.
| Device ID | K902021 |
| 510k Number | K902021 |
| Device Name: | RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | ALBION INSTRUMENTS 4745 WILEY POST WAY,650 PLAZA 6 Salt Lake City, UT 84116 |
| Contact | Hibdon, Ms |
| Correspondent | Hibdon, Ms ALBION INSTRUMENTS 4745 WILEY POST WAY,650 PLAZA 6 Salt Lake City, UT 84116 |
| Product Code | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-03 |
| Decision Date | 1990-10-09 |