The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Modification To Portable Intensive Care Unit.
| Device ID | K983307 |
| 510k Number | K983307 |
| Device Name: | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1998-11-20 |