FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYRA NASAL MASK
K Number: K031883
·
Decision Aug 25, 2003
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
24
Review Days
68
Basic Information
- Device Name
- LYRA NASAL MASK
- K Number
- K031883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SENSORMEDICS CORP.
- Date Received
- June 18, 2003
- Decision Date
- August 25, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZD), ordered by most recent decision date.
F&P Nova Nasal Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
myAir
FDA 510(k)
FDA Class 2
·Anesthesiology
WiZARD 520 Full Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
AirFit F20 Mask System; AirFit F20 NM Mask System
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiration Data Management Software (PAP Link PC)
FDA 510(k)
FDA Class 2
·Anesthesiology
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by SENSORMEDICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | Mar 4, 2004 | Substantially Equivalent |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | Feb 13, 2004 | Substantially Equivalent |
| K022192 | PEGASUS NASAL CPAP SYSTEM | Jan 24, 2003 | Substantially Equivalent |
| K020665 | HI-OX | Jul 30, 2002 | Substantially Equivalent |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | Aug 2, 2001 | Substantially Equivalent |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | Jul 24, 2001 | Substantially Equivalent |
| K991972 | INFANT FLOW SYSTEM | Aug 13, 1999 | Substantially Equivalent |
| K984254 | INFANT FLOW NCPAP MASKS | Feb 24, 1999 | Substantially Equivalent |
| K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | Oct 30, 1998 | Substantially Equivalent |
| K974303 | INFANT FLOW SYSTEM | Jan 30, 1998 | Substantially Equivalent |