FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEBULIZER, HANDHELD (T UP-DRAFT)
K Number: K760489
·
Decision Sep 3, 1976
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
33
Review Days
14
Basic Information
- Device Name
- NEBULIZER, HANDHELD (T UP-DRAFT)
- K Number
- K760489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- HUDSON OXYGEN THERAPY SALES CO.
- Date Received
- August 20, 1976
- Decision Date
- September 3, 1976
- 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 HUDSON OXYGEN THERAPY SALES CO.
| K Number | Device Name | ||
|---|---|---|---|
| K902062 | PEEP VALVE | Sep 4, 1990 | Substantially Equivalent |
| K900783 | MDI ADAPTOR | Jul 18, 1990 | Substantially Equivalent |
| K900470 | IN-THE NEBULIZER | May 18, 1990 | Substantially Equivalent |
| K895589 | MANUAL RESUSCITATOR | Mar 30, 1990 | Substantially Equivalent |
| K896136 | INFANT C.P.A.P. MONITOR | Jan 9, 1990 | Substantially Equivalent |
| K895231 | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER | Oct 27, 1989 | Substantially Equivalent |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | Oct 27, 1989 | Substantially Equivalent |
| K890035 | BACTERIA FILTER | May 5, 1989 | Substantially Equivalent |
| K870895 | NO. 1552, VALVED VENTI-COMP | May 4, 1987 | Substantially Equivalent |
| K871157 | C.P.A.P. NASAL CANNULA | Apr 21, 1987 | Substantially Equivalent |