FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMERG. OXYGEN KIT #65350 & #65399 CASE
K Number: K802644
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
18
Review Days
59
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Basic Information
- Device Name
- EMERG. OXYGEN KIT #65350 & #65399 CASE
- K Number
- K802644
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- B & F Medical Products, Inc.
- Date Received
- October 24, 1980
- Decision Date
- December 22, 1980
- 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 B & F Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | Jul 27, 1994 | Substantially Equivalent |
| K920573 | CANNULA NASAL OXYGEN | Aug 11, 1992 | Substantially Equivalent |
| K913501 | TRACHEOSTOMY MASK | Jan 13, 1992 | Substantially Equivalent |
| K861325 | MAXI-USE O2 DEVICE | Sep 9, 1986 | Substantially Equivalent |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | Apr 9, 1986 | Substantially Equivalent |
| K853004 | PORTABLE OXYGEN UNIT | Aug 29, 1985 | Substantially Equivalent |
| K843691 | PORTABLE OXYGEN UNIT | Nov 7, 1984 | Substantially Equivalent |
| K823532 | STOCK #64091-PEDIATRIC OXYGEN MASK | Jan 5, 1983 | Substantially Equivalent |
| K811404 | TRAVELAIRE | Jun 9, 1981 | Substantially Equivalent |
| K802646 | HAND PERCUSSOR CUP #65210 | Nov 12, 1980 | Substantially Equivalent |