The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Norfolk/norwich Pressure Infusion Box.
Device ID | K810954 |
510k Number | K810954 |
Device Name: | NORFOLK/NORWICH PRESSURE INFUSION BOX |
Classification | Infusor, Pressure, For I.v. Bags |
Applicant | MEDICAL INNOVATIONS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KZD |
CFR Regulation Number | 880.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-07 |
Decision Date | 1981-04-21 |