510(k) K021534
- Device
- IQ NASAL MASK, MODEL 50160 REV. D
- Applicant
- Sleepnet Corporation
- 510(k) number
- K021534
- Product code
- BZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-02
- Date received
- 2002-05-10
- Regulation
- 868.5905
- Classification name
- Ventilator, Non-Continuous (Respirator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- PAUL R CHIESA
- Address
- 1050 Perimeter Rd., Lockheed Air Center Manchester NH US 03103 03103
FDA Registration Numbers#
- 3006157842
- 3043709870
- 3003496134
- 3007421149
- 3016674860
- 3014499739
- 1924066
- 3012796943
- 3010397428
- 3010042047
- 3013154126
- 3020460367
- 3020283264
- 3011120183
- 2246552
- 3016710298
- 9611451
- 8040510
- 3023272766
- 3011205710
- 3002797442
- 1922553
- 3016733629
- 3012316249
- 2518897
- 2435947
- 3033530343
- 8043316
- 3000143502
- 2011171
- 1066270
- 3022159083
- 3006182632
- 3004713654
- 1314417
- 3021244152
- 9680721
- 3017684630
- 3030733800
- 3027344650
- 3015895383
- 8043439
- 3029227324
- 3000126629
- 3027553886
- 3008770104
- 9680215
- 1220908
- 1832562
- 3015436853
- 3003660459
- 3021091708
- 3004604967
- 3008264065
- 3010817335
- 3038236812
- 3004802249
- 3012667060
- 3011191255
- 3018783526
- 3007709321
- 3026086583
- 9680271
- 3007009701
- 3012305175
- 3042191921
- 2024500
- 9611500
- 1219313
- 3009096682
- 3011582224
- 3045063899
- 3004727093
- 3030970580
- 3013557562
- 3001400310
- 3010440667
- 3031369651
- 3004428458
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BZD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261262 | Altis Full Face Mask | Respironics, Inc. | 2026-09-25 |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| K253553 | Orion | Resmed Corp | 2026-06-04 |
| K254104 | ResScan Essentials | Resmed Corp | 2026-05-27 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | 2026-05-21 |
| 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 |