FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORT-A-BOUT 240
K Number: K772216
·
Decision Jan 5, 1978
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
33
Review Days
34
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Basic Information
- Device Name
- PORT-A-BOUT 240
- K Number
- K772216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Date Received
- December 2, 1977
- Decision Date
- January 5, 1978
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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Other Clearances by Hudson Oxygen Therapy Sales Co.
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|---|---|---|---|
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| 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 |