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 |