FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K Number: K942211
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
26
Review Days
201
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Basic Information
- Device Name
- VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
- K Number
- K942211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medics Corp.
- Date Received
- May 5, 1994
- Decision Date
- November 22, 1994
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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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 |