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 |