510(k) K234134
- Device
- AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
- Applicant
- Resmed Pty Ltd (Registration Number: 3004604967)
- 510(k) number
- K234134
- Product code
- BZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-24
- Date received
- 2023-12-29
- Regulation
- 868.5905
- Classification name
- Ventilator, Non-Continuous (Respirator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Shu-Ying Huang
- Address
- 1 Elizabeth Macarthur Dr. Bella Vista AU 2153 2153
FDA Registration Numbers
- 3009327445
- 3022159083
- 3004604967
- 8043439
- 3004727093
- 3011582224
- 2000044808
- 3004428458
- 3025360937
- 1216677
- 3007709321
- 3003862188
- 3006157842
- 3008566132
- 3021140368
- 3018783526
- 3043709870
- 3013557562
- 1219313
- 2246552
- 3019385742
- 3031369651
- 3013154126
- 2085602
- 3003496134
- 3007009701
- 3004802249
- 3013380372
- 3016710298
- 3012316249
- 3012796943
- 3011120183
- 3027553886
- 3009107628
- 3009822951
- 3030970580
- 3030733800
- 2435947
- 3006182632
- 3020283264
- 1066270
- 3012017650
- 3033530343
- 2518897
- 3031869923
- 3007421149
- 2518422
- 2029015
- 3011191255
- 3026086583
- 3016733629
- 1417592
- 3010440667
- 3015436853
- 3010397428
- 3021244152
- 9681384
- 3014449259
- 3009096682
- 3012305175
- 3011205710
- 1832562
- 9680271
- 9611451
- 2024500
- 3017684630
- 3000126629
- 3030446844
- 3010834934
- 3008264065
- 3013421741
- 3004748541
- 3016761372
- 3033526676
- 9680215
- 3027344650
- 1220477
- 3010817335
- 3012667060
- 3010272829
- 3023272766
- 1314417
- 3006446479
- 3042191921
- 9611500
- 3000143502
- 3038562397
- 3020460367
- 3002797442
- 1222088
- 3013620584
- 3013505405
- 3007573469
- 3006783791
- 3004713654
- 3021091708
- 9610849
- 9680721
- 1220908
- 3004672275
- 3010042047
- 3029706818
- 3026400132
- 1922553
- 3001400310
- 8030673
- 3015895383
- 2011171
- 3015928685
- 1924066
- 3007220521
- 8043316
- 8040510
- 3008770104
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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|---|---|---|---|
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| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026-01-15 |
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| K251770 | SleepRes PAP System | Sleepres, Inc. | 2025-12-15 |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025-12-05 |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| K250624 | myAir | Resmed Corp | 2025-05-28 |
| K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | 2025-05-23 |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | 2025-05-19 |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | 2025-01-15 |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | Genadyne Biotechnologies, Inc. | 2024-12-31 |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Sleepnet Corporation | 2024-10-18 |
| K241939 | EasyCare Tx 2 | Resmed Corp | 2024-09-27 |
| K241216 | myAir | Resmed Corp | 2024-09-26 |