FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENTIBOX
K Number: K844160
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
31
Review Days
54
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Basic Information
- Device Name
- VENTIBOX
- K Number
- K844160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Syncor Intl. Corp.
- Date Received
- October 24, 1984
- Decision Date
- December 17, 1984
- Product Code
- KPY
- 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPY), ordered by most recent decision date.
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2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
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Other Clearances by Syncor Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945825 | SECURE SAFETY INSERT | Apr 10, 1995 | Substantially Equivalent |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Sep 19, 1985 | Substantially Equivalent |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | Aug 21, 1985 | Substantially Equivalent |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | Aug 21, 1985 | Substantially Equivalent |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Aug 13, 1985 | Substantially Equivalent |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Jun 21, 1985 | Substantially Equivalent |
| K844735 | PTH-RIA | Apr 29, 1985 | Substantially Equivalent |
| K850163 | IRIDIUM 192 WIRES | Mar 26, 1985 | Substantially Equivalent |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Mar 26, 1985 | Substantially Equivalent |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Mar 26, 1985 | Substantially Equivalent |