FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQ NASAL MASK, MODEL P/N 50160
K Number: K993269
·
Decision Oct 27, 1999
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
13
Review Days
27
Basic Information
- Device Name
- IQ NASAL MASK, MODEL P/N 50160
- K Number
- K993269
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SLEEPNET CORPORATION
- Date Received
- September 30, 1999
- Decision Date
- October 27, 1999
- 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 |
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Other Clearances by SLEEPNET CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K121321 | HARD SHELL VENTED NASAL MASK | Nov 30, 2012 | Substantially Equivalent |
| K121692 | MINIME 2 NASAL MASK | Nov 5, 2012 | Substantially Equivalent |
| K120463 | MOJO, VERASEAL | Jul 27, 2012 | Substantially Equivalent |
| K102317 | IQ VENTILATION NASAL MASK | May 17, 2011 | Substantially Equivalent |
| K090935 | MINIME PEDIATRIC MASK | Jul 1, 2009 | Substantially Equivalent |
| K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED | May 17, 2007 | Substantially Equivalent |
| K060273 | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 | May 2, 2006 | Substantially Equivalent |
| K021534 | IQ NASAL MASK, MODEL 50160 REV. D | Jul 2, 2002 | Substantially Equivalent |
| K013306 | MINIME NASAL MASK, MODEL P/N 50220 | Nov 2, 2001 | Substantially Equivalent |
| K963025 | SLEEPNET HUMIDIFIER,(84200 PACKAGED) | Nov 1, 1996 | Substantially Equivalent |