The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Spirocal.
| Device ID | K791294 |
| 510k Number | K791294 |
| Device Name: | SPIROCAL |
| Classification | Calibrator, Pressure, Gas |
| Applicant | EQUILIBRATED BIO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXX |
| CFR Regulation Number | 868.2620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-10 |
| Decision Date | 1979-08-16 |