The following data is part of a premarket notification filed by Riken Keiki Co., Ltd. with the FDA for Riken Gas Indicator (3 Models, 1806h, 1802d, If-18).
| Device ID | K951366 |
| 510k Number | K951366 |
| Device Name: | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | RIKEN KEIKI CO., LTD. 12318 BIG TREE RD. Wales Center, NY 14169 -0201 |
| Contact | Allan M Bickford |
| Correspondent | Allan M Bickford RIKEN KEIKI CO., LTD. 12318 BIG TREE RD. Wales Center, NY 14169 -0201 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-08-02 |