FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
K Number: K842209
·
Decision Dec 4, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
7
Review Days
183
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
- ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
- K Number
- K842209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Armour Pharmaceutical Co.
- Date Received
- June 4, 1984
- Decision Date
- December 4, 1984
- Product Code
- LDR
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDR), ordered by most recent decision date.
DEKA Infusion System, DEKA Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
DEKA Infusion System, DEKA Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Volumetric Infusion Controller
FDA 510(k)
FDA Class 2
·General Hospital
PACER MODEL 100 INFUSION CONTROLLER
FDA 510(k)
FDA Class 2
·General Hospital
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
FDA 510(k)
FDA Class 2
·General Hospital
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Armour Pharmaceutical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | Nov 8, 1984 | Substantially Equivalent |
| K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS | Jul 27, 1984 | Substantially Equivalent |
| K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT | Jul 27, 1984 | Substantially Equivalent |
| K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT | Jul 27, 1984 | Substantially Equivalent |
| K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA | Jul 27, 1984 | Substantially Equivalent |
| K841990 | ARM-A-CARE NEBULIZER-NEBULIZER | Jul 27, 1984 | Substantially Equivalent |