The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Infusion Controller, Parenteral.
Device ID | K781216 |
510k Number | K781216 |
Device Name: | INFUSION CONTROLLER, PARENTERAL |
Classification | Monitor, Apnea, Facility Use |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLS |
CFR Regulation Number | 868.2377 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-17 |
Decision Date | 1978-08-10 |