FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
K Number: K100380
·
Decision Feb 22, 2010
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
10
Review Days
6
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Basic Information
- Device Name
- ALTERA NEBULIZER SYSTEM, MODEL 678G1002
- K Number
- K100380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pari Respiratory Equipment, Inc.
- Date Received
- February 16, 2010
- Decision Date
- February 22, 2010
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K251572 | eRapid with eTrack System | Dec 19, 2025 | Substantially Equivalent |
| K223840 | eRapid Nebulizer System | Aug 11, 2023 | Substantially Equivalent |
| K191270 | Proneb Max | Jan 23, 2020 | Substantially Equivalent |
| K162785 | Velox Nebulizer System | Apr 14, 2017 | Substantially Equivalent |
| K150044 | O-PEP | May 27, 2016 | Substantially Equivalent |
| K112859 | ERAPID NEBULIZER SYSTEM | May 30, 2012 | Substantially Equivalent |
| K092560 | PARI SINUS | May 6, 2010 | Substantially Equivalent |
| K092918 | PARI VIOS | Feb 4, 2010 | Substantially Equivalent |
| K090829 | PARI PEP S | Jul 21, 2009 | Substantially Equivalent |