The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Arkive (tm).
| Device ID | K862085 |
| 510k Number | K862085 |
| Device Name: | ARKIVE (TM) |
| Classification | Gas-machine, Anesthesia |
| Applicant | DIATEK, INC. 5720 OBERLIN DR. San Diego, CA 92121 -1723 |
| Contact | Bill Meister |
| Correspondent | Bill Meister DIATEK, INC. 5720 OBERLIN DR. San Diego, CA 92121 -1723 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-02 |
| Decision Date | 1987-01-12 |