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 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00606959050891	K083874	000
00606959048089	K083874	000
00606959047396	K083874	000
00606959047389	K083874	000
00606959039728	K083874	000