FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EL2-SERIES BLOOD COLLECTION REERVOIR
K Number: K930154
·
Decision Jul 1, 1993
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
41
Review Days
169
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Basic Information
- Device Name
- EL2-SERIES BLOOD COLLECTION REERVOIR
- K Number
- K930154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electromedics, Inc.
- Date Received
- January 13, 1993
- Decision Date
- July 1, 1993
- Product Code
- DTN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Electromedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934964 | ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR | Mar 7, 1994 | Substantially Equivalent |
| K933832 | ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR | Jan 28, 1994 | Substantially Equivalent |
| K934355 | ELECTROMEDICS BLOOD HEAT EXCHANGER | Dec 3, 1993 | Substantially Equivalent |
| K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR | Feb 19, 1993 | Substantially Equivalent |
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | Feb 5, 1993 | Substantially Equivalent |
| K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR | Sep 3, 1992 | Substantially Equivalent |
| K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 | Jun 19, 1991 | Substantially Equivalent |
| K910935 | MODIFIED PYROGEN TESTING | May 16, 1991 | Substantially Equivalent |
| K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 | Dec 13, 1990 | Substantially Equivalent |
| K903392 | ELECTROMEDICS BT422-120 AND BT422-40 | Sep 6, 1990 | Substantially Equivalent |