FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOW PRESSURE ALARM FOR OXYGEN CYLINDER
K Number: K843212
·
Decision Sep 19, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
3
Applicant Total
27
Review Days
35
Basic Information
- Device Name
- LOW PRESSURE ALARM FOR OXYGEN CYLINDER
- K Number
- K843212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2610
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- HOSPITAK, INC.
- Date Received
- August 15, 1984
- Decision Date
- September 19, 1984
- 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.
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
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PRESSURE GAUGE
FDA 510(k)
FDA Class 1
·Anesthesiology
MONITOR, GAS MANIFOLD
FDA 510(k)
FDA Class 1
·Anesthesiology
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| K953619 | WARM N WET HME W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | Nov 30, 1994 | Substantially Equivalent |
| K920842 | AEROSOL DELIVERY SYSTEMS | May 15, 1992 | Substantially Equivalent |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent |
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | Oct 26, 1987 | Substantially Equivalent |
| K853600 | INFLATABLE AIR SPLINTS | Sep 19, 1985 | Substantially Equivalent |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |