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

Saint Charles, MO, US

BC GROUP INTERNATIONAL, INC. appears in FDA device records in Saint Charles, MO. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for BC Group International Inc between 2011 and 2015. The busiest year on record is 2011, with 1. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for BC Group International Inc, by decision year
YearClearances
20111
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K153210Defibrillator Analyzer Variable LoadDRLSubstantially Equivalent
K110192DEFIBRILLATOR ANALYZER - DA-2006PDRLSubstantially Equivalent

Registered establishments

FDA registered establishments for BC Group International Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29390122939012BC GROUP INTERNATIONAL, INC.3081 Elm Point Industrial Dr, Saint Charles, MO 63301 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0457-2016DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.Class IIITerminated

Verification record

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