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 |