FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EFLOW ELECTRONIC INHALER/NEBULIZER
K Number: K033833
·
Decision May 5, 2004
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
10
Review Days
147
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Basic Information
- Device Name
- EFLOW ELECTRONIC INHALER/NEBULIZER
- K Number
- K033833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pari Innovative Manufacturers, Inc.
- Date Received
- December 10, 2003
- Decision Date
- May 5, 2004
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Pari Innovative Manufacturers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072670 | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER | Dec 13, 2007 | Substantially Equivalent |
| K072982 | PARI HYDRATE V | Nov 29, 2007 | Substantially Equivalent |
| K070498 | HYPER SAL | Apr 26, 2007 | Substantially Equivalent |
| K070107 | PARI HYDRATE G | Feb 23, 2007 | Substantially Equivalent |
| K062158 | LC SPRINT STAR | Aug 28, 2006 | Substantially Equivalent |
| K061381 | LC STAR WITH NASAL ADAPTER | Jun 2, 2006 | Substantially Equivalent |
| K060357 | TREK S NEBULIZER COMPRESSOR | Apr 5, 2006 | Substantially Equivalent |
| K060399 | LC SPRINT NEBULIZER | Mar 2, 2006 | Substantially Equivalent |
| K020944 | VORTEX VALVED HOLDING CHAMBER | May 9, 2002 | Substantially Equivalent |