FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
FLEXILOG LS
K Number: K964804
·
Decision Aug 6, 1997
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
30
Applicant Total
8
Review Days
250
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Basic Information
- Device Name
- FLEXILOG LS
- K Number
- K964804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oakfield Instruments, Ltd.
- Date Received
- November 29, 1996
- Decision Date
- August 6, 1997
- Product Code
- KLA
- 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 |
|---|---|---|---|
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Oakfield Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K964589 | FLEXILOG 3000 | Mar 4, 1997 | Substantially Equivalent |
| K961895 | FLEXILOG LS 13921 | Nov 4, 1996 | Substantially Equivalent |
| K945069 | FLEXILOG 2000 | Jun 13, 1995 | Substantially Equivalent |
| K920115 | MEDISCINT | Mar 30, 1992 | Substantially Equivalent |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Aug 28, 1990 | Substantially Equivalent |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | May 4, 1990 | Substantially Equivalent |
| K894902 | SOURCERER | Oct 17, 1989 | Substantially Equivalent |