FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO METRICS INVASIVE PRESSURE MONIT
K Number: K841960
·
Decision Nov 8, 1985
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
10
Review Days
543
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Basic Information
- Device Name
- CARDIO METRICS INVASIVE PRESSURE MONIT
- K Number
- K841960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sterile Design, Inc.
- Date Received
- May 14, 1984
- Decision Date
- November 8, 1985
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Sterile Design, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934688 | STERILE DESIGN | Mar 16, 1994 | Unknown |
| K842356 | CUSTOM STERILE PROCEDURE KITS | Mar 21, 1985 | Substantially Equivalent |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Oct 19, 1984 | Substantially Equivalent |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Oct 15, 1984 | Substantially Equivalent |
| K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT | Oct 15, 1984 | Substantially Equivalent |
| K834239 | SDI C-FLEX STERILE LIGHT HANDLE | Apr 25, 1984 | Substantially Equivalent |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | Feb 4, 1984 | Substantially Equivalent |
| K813437 | PAN SET | Dec 31, 1981 | Substantially Equivalent |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Oct 2, 1979 | Substantially Equivalent |