I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
FDA 510(k) clearance K073593 · decided 2009-01-29
Clearance details
- K-number
- K073593
- Device name
- I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
- Applicant
- Deltex Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2007-12-21
- Decision date
- 2009-01-29
- Days to decision
- 405 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Stevenage, Hertfordshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.