FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOVIEW MODEL S960000
K Number: K961056
·
Decision Jun 6, 1996
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
30
Applicant Total
16
Review Days
80
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Basic Information
- Device Name
- BIOVIEW MODEL S960000
- K Number
- K961056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sandhill Scientific, Inc.
- Date Received
- March 18, 1996
- Decision Date
- June 6, 1996
- 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 Sandhill Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111013 | ACEM | Dec 19, 2011 | Substantially Equivalent |
| K012232 | INSIGHT, MODEL S980000 | Jun 7, 2002 | Substantially Equivalent |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Feb 28, 2002 | Substantially Equivalent |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 | Jun 22, 2001 | Substantially Equivalent |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | May 12, 1999 | Substantially Equivalent |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | Jan 11, 1999 | Substantially Equivalent |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | Apr 9, 1996 | Substantially Equivalent |
| K941801 | ANALGRAPH | Sep 8, 1995 | Substantially Equivalent |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sep 28, 1994 | Substantially Equivalent |
| K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | Aug 26, 1994 | Substantially Equivalent |