The following data is part of a premarket notification filed by Medx Electronics, Inc. with the FDA for Medx 1000 Series.
Device ID | K020017 |
510k Number | K020017 |
Device Name: | MEDX 1000 SERIES |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | MEDX ELECTRONICS, INC. 513 BASHFORD LN. SUITE 5 Alexandria, VA 22314 |
Contact | Robin Wiley |
Correspondent | Robin Wiley MEDX ELECTRONICS, INC. 513 BASHFORD LN. SUITE 5 Alexandria, VA 22314 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-03 |
Decision Date | 2002-07-12 |
Summary: | summary |