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

Phoenix, AZ, US

CARDIONET, LLC appears in FDA device records in Phoenix, AZ. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. 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
7
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Cardionet, LLC between 2001 and 2010. The busiest year on record is 2006, with 2. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cardionet, LLC, by decision year
YearClearances
20011
20021
20051
20062
20071
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K093288CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTIONQYXSubstantially Equivalent
K072558CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005QYXSubstantially Equivalent
K063222CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004QYXSubstantially Equivalent
K053263CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003DSISubstantially Equivalent
K052240CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002QYXSubstantially Equivalent
K012241CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001DSISubstantially Equivalent
K003707CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000AMWJSubstantially Equivalent

Registered establishments

FDA registered establishments for Cardionet, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087736473008773647CARDIONET, LLC5750 S. 40th St Suite 5, Phoenix, AZ 85040 US2026
30168124243016812424CARDIONET, LLC600 West Ridge Road, Linwood, PA 19061 US2026

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