The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Dispiro.
| Device ID | K791177 |
| 510k Number | K791177 |
| Device Name: | DISPIRO |
| Classification | Spirometer, Diagnostic |
| Applicant | UTAH MEDICAL PRODUCTS, 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 | 1979-06-25 |
| Decision Date | 1979-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671020091 | K791177 | 000 |
| H671020201 | K791177 | 000 |
| H671020401 | K791177 | 000 |
| H671024001 | K791177 | 000 |
| H671024011 | K791177 | 000 |
| H671024511 | K791177 | 000 |
| H671024601 | K791177 | 000 |
| H671024611 | K791177 | 000 |
| H671025001 | K791177 | 000 |
| H6719502452 | K791177 | 000 |
| H671020001 | K791177 | 000 |
| H671020011 | K791177 | 000 |
| H671020021 | K791177 | 000 |
| H671020131 | K791177 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DISPIRO 73419541 1280628 Dead/Cancelled |
Utah Medical Products, Inc. 1983-03-31 |