The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Knightcontrol Remote Control, Model M-114700-us.
Device ID | K063501 |
510k Number | K063501 |
Device Name: | KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | MALLINCKRODT DEVELOPPEMENT FRANCE 4280 HACIENDA DR. Pleasanton, CA 94588 |
Contact | James Bonds |
Correspondent | James Bonds MALLINCKRODT DEVELOPPEMENT FRANCE 4280 HACIENDA DR. Pleasanton, CA 94588 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-20 |
Decision Date | 2007-04-06 |
Summary: | summary |