ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
FDA 510(k) clearance K120624 · decided 2012-06-08
Clearance details
- K-number
- K120624
- Device name
- ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
- Applicant
- Elcam Medical Acal
- Decision
- Substantially Equivalent
- Date received
- 2012-03-01
- Decision date
- 2012-06-08
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kibbutz Baram, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.