FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACEM
K Number: K111013
·
Decision Dec 19, 2011
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
16
Review Days
252
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Basic Information
- Device Name
- ACEM
- K Number
- K111013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sandhill Scientific, Inc.
- Date Received
- April 11, 2011
- Decision Date
- December 19, 2011
- Product Code
- FFZ
- 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 |
|---|---|---|---|
| FFZ | Cord, Electric, For Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFZ), ordered by most recent decision date.
ELECTRIC CORD FOR ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
C-CORD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Sandhill Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K961056 | BIOVIEW MODEL S960000 | Jun 6, 1996 | 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 |