510(k) K233555
- Device
- AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- Applicant
- Philips Respironics
- 510(k) number
- K233555
- Product code
- BZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-31
- Date received
- 2023-11-06
- 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
Related Records
Applicant Contact
- Contact
- Emily Tobin
- Address
- 1001 Murry Ridge Ln. Murrysville PA US 15668 15668
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
Source Documents
Other 510(k) Records For Product Code BZD
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026-01-15 |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026-01-07 |
| 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 |