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 |