GALAXY

Ventilatory Effort Recorder

RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP

The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Galaxy.

Pre-market Notification Details

Device IDK083874
510k NumberK083874
Device Name:GALAXY
ClassificationVentilatory Effort Recorder
Applicant RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactAndrew P Zeltwanger
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-12-29
Decision Date2009-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959050891 K083874 000
00606959048089 K083874 000
00606959047396 K083874 000
00606959047389 K083874 000
00606959039728 K083874 000

Trademark Results [GALAXY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAXY
GALAXY
98447911 not registered Live/Pending
Lancaster Archery Supply, Inc.
2024-03-13
GALAXY
GALAXY
98360485 not registered Live/Pending
Quanzhou Niceway Import &Export Co., Ltd.
2024-01-17
GALAXY
GALAXY
98307253 not registered Live/Pending
Starship Sloane Publishing Company, Inc.
2023-12-10
GALAXY
GALAXY
98275133 not registered Live/Pending
Jasco Products Company LLC
2023-11-17
GALAXY
GALAXY
98192206 not registered Live/Pending
Spogen Biotech, Inc.
2023-09-22
GALAXY
GALAXY
98049935 not registered Live/Pending
GALAXY RESOURCES PTY LTD
2023-06-20
GALAXY
GALAXY
98049447 not registered Live/Pending
Shenzhen Baiweiju Catering Management Co., Ltd.
2023-06-19
GALAXY
GALAXY
98045785 not registered Live/Pending
Sun Pharma, LLC
2023-06-16
GALAXY
GALAXY
97775040 not registered Live/Pending
Rayner Surgical Group Limited
2023-01-31
GALAXY
GALAXY
97764041 not registered Live/Pending
Edens Technologies, LLC
2023-01-23
GALAXY
GALAXY
97764032 not registered Live/Pending
Edens Technologies, LLC
2023-01-23
GALAXY
GALAXY
97696283 not registered Live/Pending
Odyssey Design and Manufacturing, Inc.
2022-11-29

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