FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
K Number: K942645
·
Decision Jul 27, 1994
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
18
Review Days
54
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Basic Information
- Device Name
- B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
- K Number
- K942645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2610
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- B & F Medical Products, Inc.
- Date Received
- June 3, 1994
- Decision Date
- July 27, 1994
- Product Code
- BXH
- 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 |
|---|---|---|---|
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXH), ordered by most recent decision date.
PRESSURE GAUGE
FDA 510(k)
FDA Class 1
·Anesthesiology
LOW PRESSURE ALARM FOR OXYGEN CYLINDER
FDA 510(k)
FDA Class 1
·Anesthesiology
MONITOR, GAS MANIFOLD
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by B & F Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | Dec 22, 1980 | Substantially Equivalent |
| K802646 | HAND PERCUSSOR CUP #65210 | Nov 12, 1980 | Substantially Equivalent |