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  |