FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYSHUTTLE II ,MODIFICATION
K Number: K925542
·
Decision Feb 17, 1993
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
26
Review Days
121
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Basic Information
- Device Name
- OXYSHUTTLE II ,MODIFICATION
- K Number
- K925542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medics Corp.
- Date Received
- October 19, 1992
- Decision Date
- February 17, 1993
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Sensor Medics 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 |
| K031883 | LYRA NASAL MASK | Aug 25, 2003 | Substantially Equivalent |
| K030943 | MODIFICATION TO HIOX | Apr 22, 2003 | 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 |