The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Disposa-hood.
Device ID | K792144 |
510k Number | K792144 |
Device Name: | DISPOSA-HOOD |
Classification | Hood, Oxygen, Infant |
Applicant | UTAH MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOG |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-23 |
Decision Date | 1979-12-05 |