FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEB-90 LARGE VOLUME MEDICATION NEBULIZER
K Number: K080657
·
Decision Jun 30, 2008
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
9
Review Days
115
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Basic Information
- Device Name
- NEB-90 LARGE VOLUME MEDICATION NEBULIZER
- K Number
- K080657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medi Nuclear Corp., Inc.
- Date Received
- March 7, 2008
- Decision Date
- June 30, 2008
- 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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Other Clearances by Medi Nuclear Corp., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082541 | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM | Nov 26, 2008 | Substantially Equivalent |
| K080969 | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 | Jul 25, 2008 | Substantially Equivalent |
| K915075 | NEBULIZER (DIRECT PATIENT INTERFACE) | Jul 16, 1992 | Substantially Equivalent |
| K865107 | AERO-VENT AEROSOL UNIT | Oct 20, 1987 | Substantially Equivalent |
| K865093 | SAFE-T-SHIELD MOUTHPIECE | Jan 15, 1987 | Substantially Equivalent |
| K863996 | MODEL XE-103 XENON/MASTER II | Nov 4, 1986 | Substantially Equivalent |
| K813379 | RADIONUCLIDE DOSE CALIBRATOR | Jan 22, 1982 | Substantially Equivalent |
| K810819 | MEDI/NUCLEAR #XE-102 XENON/MASTER | Apr 14, 1981 | Substantially Equivalent |