FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO'TECT
K Number: K943558
·
Decision May 24, 1995
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
36
Applicant Total
4
Review Days
306
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Basic Information
- Device Name
- PRO'TECT
- K Number
- K943558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.2040
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Sense Intl., Inc.
- Date Received
- July 22, 1994
- Decision Date
- May 24, 1995
- Product Code
- KPN
- 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 |
|---|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | FDA class 2 | Gastroenterology, Urology |
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