ACTICAL

Conditioner, Signal, Physiological

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Actical.

Pre-market Notification Details

• Device ID: K060919
• 510k Number: K060919
• Device Name: ACTICAL
• Classification: Conditioner, Signal, Physiological
• Applicant: RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Contact: Zita A Yurko
• Correspondent: Neil E Devine; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: GWK
• CFR Regulation Number: 882.1845 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-04-04
• Decision Date: 2006-09-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00606959021006	K060919	000