FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTRUM DG-P7000 PEDIATRIC CRADLE
K Number: K933134
·
Decision Oct 7, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
9
Review Days
101
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Basic Information
- Device Name
- SPECTRUM DG-P7000 PEDIATRIC CRADLE
- K Number
- K933134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1830
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum X-Ray Corp.
- Date Received
- June 28, 1993
- Decision Date
- October 7, 1993
- Product Code
- KXH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KXH | Cradle, Patient, Radiologic | FDA class 1 | Radiology |
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Other Clearances by Spectrum X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931563 | SPECTRUM MARK I SPECIAL PROCEDURES TABLE | Aug 23, 1993 | Substantially Equivalent |
| K870707 | PENTAMAX 1 MODEL B TABLE SYSTEM | May 14, 1987 | Substantially Equivalent |
| K834494 | SPECTRUM X-RAY CORP | Feb 21, 1984 | Substantially Equivalent |
| K840463 | DIGITAL CRADLE | Feb 21, 1984 | Substantially Equivalent |
| K827450 | SIMPLAMATIC III | May 19, 1982 | Substantially Equivalent |
| K813561 | SPECTRUM PEDIATRIC CARDLE TABLE | Jan 29, 1982 | Substantially Equivalent |
| K791812 | SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM | Nov 5, 1979 | Substantially Equivalent |
| K791811 | SPECTRUM AUTOMATIC CHEST UNIT MODEL C | Oct 26, 1979 | Substantially Equivalent |