The following data is part of a premarket notification filed by Spica, Inc. with the FDA for Analgesia Units, Oxygen & Nitrate Device.
| Device ID | K800801 |
| 510k Number | K800801 |
| Device Name: | ANALGESIA UNITS, OXYGEN & NITRATE DEVICE |
| Classification | Gas-machine, Anesthesia |
| Applicant | SPICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-10 |
| Decision Date | 1980-05-28 |