The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Model Am 722.
Device ID | K810203 |
510k Number | K810203 |
Device Name: | MODEL AM 722 |
Classification | Electrode, Ion Specific, Calcium |
Applicant | APPLIED MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFP |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-23 |
Decision Date | 1981-02-10 |