FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
K Number: K973875
·
Decision Jan 26, 1998
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
4
Applicant Total
172
Review Days
108
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Basic Information
- Device Name
- RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
- K Number
- K973875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5550
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- October 10, 1997
- Decision Date
- January 26, 1998
- Product Code
- KMA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KMA | Irrigator, Powered Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMA), ordered by most recent decision date.
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
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RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
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FDA Class 1
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MICROFLOW IRRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
POWDER BLOWERS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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