FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURE GAUGE
K Number: K853040
·
Decision Oct 10, 1985
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
5
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PRESSURE GAUGE
- K Number
- K853040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2610
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Erie Medical
- Date Received
- July 19, 1985
- Decision Date
- October 10, 1985
- 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
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