The following data is part of a premarket notification filed by Iso-data, Inc. with the FDA for Dpm Calculator.
Device ID | K810631 |
510k Number | K810631 |
Device Name: | DPM CALCULATOR |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | ISO-DATA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-10 |
Decision Date | 1981-03-27 |