The following data is part of a premarket notification filed by Deltex Medical Limited with the FDA for I2s Doppler Probe ( 6 Hour), I2s Doppler Probe (24 Hour), I2c Doppler Probe (72 Hour), Models 9090-7015, 9090-7016.
| Device ID | K073593 |
| 510k Number | K073593 |
| Device Name: | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | DELTEX MEDICAL LIMITED BUSINESS & TECHNOLOGY CENTER/ BESSEMER DRIVE Stevenage, Hertfordshire, GB Sg1 2dx |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong DELTEX MEDICAL LIMITED BUSINESS & TECHNOLOGY CENTER/ BESSEMER DRIVE Stevenage, Hertfordshire, GB Sg1 2dx |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-21 |
| Decision Date | 2009-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055679400090 | K073593 | 000 |
| 5055679401745 | K073593 | 000 |
| 5055679401547 | K073593 | 000 |