FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUZZY BEAR ENURESIS ALARM
K Number: K895852
·
Decision Feb 12, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
36
Applicant Total
1
Review Days
132
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Basic Information
- Device Name
- BUZZY BEAR ENURESIS ALARM
- K Number
- K895852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.2040
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Med-Design, Inc.
- Date Received
- October 3, 1989
- Decision Date
- February 12, 1990
- 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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