The following data is part of a premarket notification filed by Event Medical Ltd with the FDA for Medical Air Compressor.
Device ID | K040220 |
510k Number | K040220 |
Device Name: | MEDICAL AIR COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | EVENT MEDICAL LTD 6A LIOSBAN BUSINESS PARK TUAM ROAD Galway, IE |
Contact | Robbie Walsh |
Correspondent | Robbie Walsh EVENT MEDICAL LTD 6A LIOSBAN BUSINESS PARK TUAM ROAD Galway, IE |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-02 |
Decision Date | 2004-06-09 |
Summary: | summary |