FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K Number: K874020
·
Decision Jan 29, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
883
Review Days
119
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Basic Information
- Device Name
- ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
- K Number
- K874020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 2, 1987
- Decision Date
- January 29, 1988
- Product Code
- KPF
- 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 |
|---|---|---|---|
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | FDA class 2 | Gastroenterology, Urology |
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