The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Portable Intensive Care Unit, Model Pic.
Device ID | K000712 |
510k Number | K000712 |
Device Name: | PORTABLE INTENSIVE CARE UNIT, MODEL PIC |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
Contact | Joel Orlinsky |
Correspondent | Joel Orlinsky MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 Buffalo Grove, IL 60089 |
Product Code | CCK |
Subsequent Product Code | LDD |
Subsequent Product Code | MKJ |
Subsequent Product Code | MWI |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-02 |
Decision Date | 2000-04-27 |