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510(k) Submission – K230476
510(k) Submission – K230476
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510(K) Number: K230476
Device Name: Oran Park Mask
Manufacturer: ResMed Pty Ltd (Registration Number: 3004604967)
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 02/22/2023
Decision Date: 10/19/2023
Regulation Medical Specialty: Anesthesiology
Request Contents: K230476
Device Name: Oran Park Mask
Manufacturer: ResMed Pty Ltd (Registration Number: 3004604967)
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 02/22/2023
Decision Date: 10/19/2023
Regulation Medical Specialty: Anesthesiology
Request Contents: K230476
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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