FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
K Number: K860704
·
Decision Jun 17, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
29
Review Days
111
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Basic Information
- Device Name
- THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
- K Number
- K860704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Keymed, Inc.
- Date Received
- February 26, 1986
- Decision Date
- June 17, 1986
- Product Code
- NZA
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Keymed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Apr 22, 2010 | Substantially Equivalent |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Mar 29, 1993 | Substantially Equivalent |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | May 12, 1988 | Substantially Equivalent |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Feb 12, 1987 | Substantially Equivalent |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Dec 24, 1986 | Substantially Equivalent |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Aug 12, 1986 | Substantially Equivalent |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Jul 15, 1986 | Substantially Equivalent |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Jun 23, 1986 | Substantially Equivalent |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Nov 26, 1985 | Substantially Equivalent |
| K854304 | KEYMED OFFICE COUCH | Nov 12, 1985 | Substantially Equivalent |