The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Spirometric Computer #sc-10.
| Device ID | K802928 |
| 510k Number | K802928 |
| Device Name: | SPIROMETRIC COMPUTER #SC-10 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1980-12-17 |