The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Autospirometer Hi-498.
| Device ID | K820599 |
| 510k Number | K820599 |
| Device Name: | AUTOSPIROMETER HI-498 |
| Classification | Spirometer, Diagnostic |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-04 |
| Decision Date | 1982-04-15 |