FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K Number: K961070
·
Decision Jun 11, 1996
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
30
Applicant Total
5
Review Days
85
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Basic Information
- Device Name
- ESOPHAGEAL MANOMETRY ANALYSIS MODULE
- K Number
- K961070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synectics Medical, Inc.
- Date Received
- March 18, 1996
- Decision Date
- June 11, 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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