FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASTER FLOW I.V. PUMPETTE
K Number: K905497
·
Decision Apr 16, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
6
Review Days
130
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Basic Information
- Device Name
- MASTER FLOW I.V. PUMPETTE
- K Number
- K905497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Master Medical Corp.
- Date Received
- December 7, 1990
- Decision Date
- April 16, 1991
- 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 |
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Other Clearances by The Master Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K913076 | I.V. INSTANT TIMER | Oct 17, 1991 | Substantially Equivalent |
| K905498 | STAT 2 IV PUMPETTE | Apr 16, 1991 | Substantially Equivalent |
| K871753 | MASTER MEDICAL DEVICE IS I.V. STAT 2 | Jun 5, 1987 | Substantially Equivalent |
| K852254 | I.V. STAT MASTER | Nov 18, 1985 | Substantially Equivalent |
| K792560 | MASTER I.V. DIAL LOCK | Dec 20, 1979 | Substantially Equivalent |