The following data is part of a premarket notification filed by Biomaterials International, Inc. with the FDA for Rascal Anesthesia Respiratory Gas Analyzor.
| Device ID | K855108 |
| 510k Number | K855108 |
| Device Name: | RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | BIOMATERIALS INTERNATIONAL, INC. P.O. BOX 8852, RESEARCH PARK 420 CHIPETA WAY, SUITE 160 Salt Lake City, UT 84108 -0852 |
| Contact | Coleman Ph.d. |
| Correspondent | Coleman Ph.d. BIOMATERIALS INTERNATIONAL, INC. P.O. BOX 8852, RESEARCH PARK 420 CHIPETA WAY, SUITE 160 Salt Lake City, UT 84108 -0852 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-02-21 |