FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSFER TROLLEY
K Number: K841396
·
Decision May 7, 1984
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
19
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- TRANSFER TROLLEY
- K Number
- K841396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Setma, Inc.
- Date Received
- April 3, 1984
- Decision Date
- May 7, 1984
- Product Code
- FDA
- 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 |
|---|---|---|---|
| FDA | Enteroscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Setma, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854861 | SETMA HYGIA BATH MODEL ST 7200 | Jan 3, 1986 | Substantially Equivalent |
| K854263 | SETMA FHT, MODEL ST 8130 | Nov 13, 1985 | Substantially Equivalent |
| K853163 | SETMA VHT | Nov 5, 1985 | Substantially Equivalent |
| K841397 | BURN BATH | May 18, 1984 | Substantially Equivalent |
| K841395 | SHOWER TROLLEY | May 7, 1984 | Substantially Equivalent |
| K841398 | VARIABLE HEIGHT TRANSFER CHAIR | May 7, 1984 | Substantially Equivalent |