Care Orchestrator

Ventilator, Non-continuous (respirator)

Respironics Inc.

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

Pre-market Notification Details

• Device ID: K181053
• 510k Number: K181053
• Device Name: Care Orchestrator
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
• Contact: Ankitha Rao
• Correspondent: Ankitha Rao; Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
• Product Code: BZD
• Subsequent Product Code: CAW
• Subsequent Product Code: CBK
• Subsequent Product Code: MNS
• Subsequent Product Code: MNT
• Subsequent Product Code: NOU
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-20
• Decision Date: 2019-01-04
• Summary: summary