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
Related Records
Applicant Contact
- Contact
- PAUL R CHIESA
- Address
- 1050 Perimeter Rd., Lockheed Air Center Manchester NH US 03103 03103
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
510(k) summary PDF not indicated by FDA
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