FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HELIOX LOW FLOW SENTRY BLENDER
K Number: K092484
·
Decision Apr 2, 2010
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
5
Review Days
232
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Basic Information
- Device Name
- HELIOX LOW FLOW SENTRY BLENDER
- K Number
- K092484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinal Health 207, Inc.
- Date Received
- August 13, 2009
- Decision Date
- April 2, 2010
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
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Other Clearances by Cardinal Health 207, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093094 | VELA VENTILATOR | May 11, 2010 | Substantially Equivalent |
| K093124 | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 | Mar 10, 2010 | Substantially Equivalent |
| K081670 | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK | Oct 9, 2008 | Substantially Equivalent |
| K081837 | AVEA VENTILATOR | Aug 13, 2008 | Substantially Equivalent |