The following data is part of a premarket notification filed by Respiratory Delivery Systems, Inc. with the FDA for Microchamber.
Device ID | K915211 |
510k Number | K915211 |
Device Name: | MICROCHAMBER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | RESPIRATORY DELIVERY SYSTEMS, INC. 70 MOUNT HOPE ST. Lowell, MA 01854 |
Contact | Walter J Makiej |
Correspondent | Walter J Makiej RESPIRATORY DELIVERY SYSTEMS, INC. 70 MOUNT HOPE ST. Lowell, MA 01854 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-18 |
Decision Date | 1992-05-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROCHAMBER 78216680 not registered Dead/Abandoned |
SCP GLOBAL TECHNOLOGIES, INC. 2003-02-19 |
MICROCHAMBER 76295346 not registered Dead/Abandoned |
SCP GLOBAL TECHNOLOGIES, INC. 2001-08-02 |
MICROCHAMBER 74537563 1948129 Live/Registered |
Conservation Resources International, Inc. 1994-06-14 |
MICROCHAMBER 74537562 1948128 Live/Registered |
Conservation Resources International, Inc. 1994-06-14 |
MICROCHAMBER 74410576 1891995 Live/Registered |
FORMFACTOR BEAVERTON, INC. 1993-07-09 |
MICROCHAMBER 74401657 2099671 Live/Registered |
Respiratory Delivery Systems, Inc. 1993-06-14 |
MICROCHAMBER 74210435 not registered Dead/Abandoned |
Respiratory Delivery Systems, Inc. 1991-10-07 |