FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K Number: K120624
·
Decision Jun 8, 2012
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
16
Review Days
99
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Basic Information
- Device Name
- ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
- K Number
- K120624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elcam Medical Acal
- Date Received
- March 1, 2012
- Decision Date
- June 8, 2012
- 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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