The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Jump Start, Model 970300.
Device ID | K021168 |
510k Number | K021168 |
Device Name: | JUMP START, MODEL 970300 |
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 | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-11 |
Decision Date | 2002-06-26 |