The following data is part of a premarket notification filed by Allied Medical Technologies, Inc. with the FDA for Iv Alert System.
Device ID | K820200 |
510k Number | K820200 |
Device Name: | IV ALERT SYSTEM |
Classification | Container, I.v. |
Applicant | ALLIED MEDICAL TECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-26 |
Decision Date | 1982-03-18 |