The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Medistor Iii Lung Analyzer.
Device ID | K800547 |
510k Number | K800547 |
Device Name: | MEDISTOR III LUNG ANALYZER |
Classification | Calculator, Pulmonary Function Data |
Applicant | CYBERMEDIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-10 |
Decision Date | 1980-03-25 |