510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073593Substantially Equivalent

I2s Doppler Probe ( 6 Hour), I2s Doppler Probe (24 Hour), I2c Doppler Probe (72 Hour), Models 9090-7015, 9090-7016

Deltex Medical Limited, Stevenage, Hertfordshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073593 is the FDA 510(k) clearance record for I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016, a class II device, cleared for Deltex Medical Limited on under FDA product code DPT (Probe, Blood-Flow, Extravascular). FDA records list 9 510(k) clearances for Deltex Medical Limited, from to . As of , FDA records show no recalls naming K073593.

Clearance record

Decision date
Received
(405 days to decision)
Product code
DPT Probe, Blood-Flow, Extravascular
Regulation
21 CFR 870.2120
Device class
Class II
Review panel
Cardiovascular
Applicant
Deltex Medical Limited Business & Technology Center/, Stevenage, Hertfordshire, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPT

Trailing 12 months

FDA records hold no clearances under product code DPT in the trailing twelve months.

FDA records show no clearances under product code DPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260