The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Galaxy.
Device ID | K083874 |
510k Number | K083874 |
Device Name: | GALAXY |
Classification | Ventilatory Effort Recorder |
Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
Contact | Andrew P Zeltwanger |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | MNR |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-12-29 |
Decision Date | 2009-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00606959050891 | K083874 | 000 |
00606959048089 | K083874 | 000 |
00606959047396 | K083874 | 000 |
00606959047389 | K083874 | 000 |
00606959039728 | K083874 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GALAXY 98447911 not registered Live/Pending |
Lancaster Archery Supply, Inc. 2024-03-13 |
GALAXY 98360485 not registered Live/Pending |
Quanzhou Niceway Import &Export Co., Ltd. 2024-01-17 |
GALAXY 98307253 not registered Live/Pending |
Starship Sloane Publishing Company, Inc. 2023-12-10 |
GALAXY 98275133 not registered Live/Pending |
Jasco Products Company LLC 2023-11-17 |
GALAXY 98192206 not registered Live/Pending |
Spogen Biotech, Inc. 2023-09-22 |
GALAXY 98049935 not registered Live/Pending |
GALAXY RESOURCES PTY LTD 2023-06-20 |
GALAXY 98049447 not registered Live/Pending |
Shenzhen Baiweiju Catering Management Co., Ltd. 2023-06-19 |
GALAXY 98045785 not registered Live/Pending |
Sun Pharma, LLC 2023-06-16 |
GALAXY 97775040 not registered Live/Pending |
Rayner Surgical Group Limited 2023-01-31 |
GALAXY 97764041 not registered Live/Pending |
Edens Technologies, LLC 2023-01-23 |
GALAXY 97764032 not registered Live/Pending |
Edens Technologies, LLC 2023-01-23 |
GALAXY 97696283 not registered Live/Pending |
Odyssey Design and Manufacturing, Inc. 2022-11-29 |