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

CHICHESTER West Sussex, GB

DELTEX MEDICAL LIMITED appears in FDA device records in CHICHESTER West Sussex, GB. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Deltex Medical Limited between 1995 and 2018. The busiest year on record is 2015, with 2. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Deltex Medical Limited, by decision year
YearClearances
19951
20031
20061
20091
20111
20131
20152
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDPWSubstantially Equivalent
K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DPWSubstantially Equivalent
K142932Deltex Medical KDP72 Doppler ProbeDPTSubstantially Equivalent
K132139DELTEX MEDICAL CARDIOQ-EDM+DPWSubstantially Equivalent
K111542DELTEX MEDICAL CARDIOQ EDMDPWSubstantially Equivalent
K073593I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016DPTSubstantially Equivalent
K052989DP240 240 HOUR DOPPLER PROBEDPTSubstantially Equivalent
K031706CARDIOQ, MODEL 9051-7005DPWSubstantially Equivalent
K951369EDMDPWSubstantially Equivalent

Registered establishments

FDA registered establishments for Deltex Medical Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96809331000637007DELTEX MEDICAL LIMITEDTERMINUS RD., CHICHESTER West Sussex PO19 8TX GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain