FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I.V. DRIP MONITOR ALARM DEVICE, MONIFLO
K Number: K760931
·
Decision Jan 5, 1977
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
38
Applicant Total
12
Review Days
68
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Basic Information
- Device Name
- I.V. DRIP MONITOR ALARM DEVICE, MONIFLO
- K Number
- K760931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Diemolding Corp.
- Date Received
- October 29, 1976
- Decision Date
- January 5, 1977
- Product Code
- FLN
- 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 |
|---|---|---|---|
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | FDA class 2 | General Hospital |
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Other Clearances by Diemolding Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962749 | THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT | Oct 10, 1996 | Substantially Equivalent |
| K961455 | MEDSHIELD/AEROCHAMBER | Jul 25, 1996 | Substantially Equivalent |
| K902713 | ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS | Jul 25, 1990 | Substantially Equivalent |
| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Jul 18, 1990 | Substantially Equivalent |
| K900754 | RESPIREX 2 | Mar 15, 1990 | Substantially Equivalent |
| K893791 | BREATHING MOUTHPIECE | Jun 23, 1989 | Substantially Equivalent |
| K781759 | RESCAL | Nov 27, 1978 | Substantially Equivalent |
| K780750 | O2 CONNECTOR | Jul 27, 1978 | Substantially Equivalent |
| K770369 | VACON TM | Mar 1, 1977 | Substantially Equivalent |
| K760636 | ORTHOMIX | Oct 5, 1976 | Substantially Equivalent |