FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DIAL MEDICAL KIT
K Number: K941543
·
Decision Feb 16, 1995
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
21
Review Days
323
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Basic Information
- Device Name
- DIAL MEDICAL KIT
- K Number
- K941543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Regulatory & Marketing Services, Inc.
- Date Received
- March 30, 1994
- Decision Date
- February 16, 1995
- Product Code
- KOC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
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Blood Tubing Lines for Hemodialysis AV06C-E
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Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
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CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
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CAREline Airless Hemodialysis Blood Tubing Sets
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Other Clearances by Regulatory & Marketing Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Apr 10, 1996 | Substantially Equivalent |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | Oct 30, 1995 | Substantially Equivalent |
| K941342 | PAIN DOC | Oct 13, 1995 | Substantially Equivalent |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Feb 15, 1995 | Substantially Equivalent |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | Dec 27, 1994 | Substantially Equivalent |
| K944383 | ORION RED URETHRAL CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944377 | ORION'S URINARY DRAINAGE SET | Dec 6, 1994 | Substantially Equivalent |