FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
K Number: K234134
·
Decision Sep 24, 2024
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
3
Review Days
270
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
- K Number
- K234134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed Pty Ltd (Registration Number: 3004604967)
- Date Received
- December 29, 2023
- Decision Date
- September 24, 2024
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZD), ordered by most recent decision date.
Orion
FDA 510(k)
FDA Class 2
·Anesthesiology
ResScan Essentials
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
FDA 510(k)
FDA Class 2
·Anesthesiology
MySleepDash
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology