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

Bothell, WA, US

Diagnostic Ultrasound Corp. appears in FDA device records in Bothell, WA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Diagnostic Ultrasound Corp. between 1985 and 2003. The busiest year on record is 1991, with 4. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Diagnostic Ultrasound Corp., by decision year
YearClearances
19851
19902
19914
19922
19931
19963
19991
20021
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K030763DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEMIYOSubstantially Equivalent
K022153BLADDERSCAN BVI 6100IYOSubstantially Equivalent
K982568BLADDERMANAGER PCI 5000 MODEL 1002ITXSubstantially Equivalent
K963585BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000IYOSubstantially Equivalent
K955840BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000IYOSubstantially Equivalent
K955942BLADDERSCAN BVI 5000IYOSubstantially Equivalent
K920664DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSIONFFXSubstantially Equivalent
K915342UD 2000 VIDEO OPTIONLLZSubstantially Equivalent
K915436BLADDERSCAN BVI 2500IYOSubstantially Equivalent
K911166DIAGNOSTIC ULTRASOUND/URO-GYN UD 511DXTSubstantially Equivalent
K911125DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020FAPSubstantially Equivalent
K911091DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIESFAPSubstantially Equivalent
K904792DIAGNOSTIC ULTRASOUND VERSADOPP 1000DPWSubstantially Equivalent
K902692DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002FAPSubstantially Equivalent
K902408DIAGNOSTIC ULTRASOUND UFS 1005EXYSubstantially Equivalent
K842539DIAGNOSTIC ULTRASOUND 105 & 110JOPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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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What MDM checks, and what it does not

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