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

Walker, MI, US

Biosensor Corp. appears in FDA device records in Walker, MI. FDA records list 10 510(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
10
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 10 510(k) clearances for Biosensor Corp. between 1983 and 1999. The busiest year on record is 1996, with 4. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biosensor Corp., by decision year
YearClearances
19831
19901
19931
19964
19982
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005DQKSubstantially Equivalent
K974546BIOSENSOR HOLTER MONITOR SYSTEMDQKSubstantially Equivalent
K974192BIOSENSOR HOLTER MONITOR SYSTEMDQKSubstantially Equivalent
K950944AMBULATORY (HOLTER) RECORDING SYSTEMDQKSubstantially Equivalent
K960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)DPSSubstantially Equivalent
K943338BIOSENSOR BIDOP VASCULAR TEST SYSTEMJAFSubstantially Equivalent
K950723AMBULATORY (HOLTER) RECORDING SYSTEMDQKSubstantially Equivalent
K922027AMBULATORY (HOLTER) RECORDING, MODIFICATIONDSISubstantially Equivalent
K895266AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIEDDSISubstantially Equivalent
K831676BIOSENSOR ASC SYSTEMDSISubstantially 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