FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
K Number: K881004
·
Decision May 12, 1988
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
29
Review Days
64
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Basic Information
- Device Name
- OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
- K Number
- K881004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Keymed, Inc.
- Date Received
- March 9, 1988
- Decision Date
- May 12, 1988
- Product Code
- FCX
- 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 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 |
| 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 |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Jun 17, 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 |