FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-OX
K Number: K020665
·
Decision Jul 30, 2002
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
102
Applicant Total
24
Review Days
151
Basic Information
- Device Name
- HI-OX
- K Number
- K020665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SENSORMEDICS CORP.
- Date Received
- March 1, 2002
- Decision Date
- July 30, 2002
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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Other Clearances by SENSORMEDICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | Mar 4, 2004 | Substantially Equivalent |
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| K031883 | LYRA NASAL MASK | Aug 25, 2003 | Substantially Equivalent |
| K022192 | PEGASUS NASAL CPAP SYSTEM | Jan 24, 2003 | 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 |