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 |