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FDA 510(k)

DEFIBRILLATOR ANALYZER - DA-2006P

K-Number: K110192 · 2011-02-08

ApplicantBc Group International, Inc.
Decision Date2011-02-08
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEFIBRILLATOR ANALYZER - DA-2006P is the device name listed in this FDA 510(k) record. The listed applicant is Bc Group International, Inc.. It received FDA 510(k) clearance on 2011-02-08 under 510(k) number K110192. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFIBRILLATOR ANALYZER - DA-2006P?

DEFIBRILLATOR ANALYZER - DA-2006P is a medical device that received FDA 510(k) clearance on 2011-02-08. The listed applicant is Bc Group International, Inc.. The 510(k) number is K110192.

When did DEFIBRILLATOR ANALYZER - DA-2006P receive FDA 510(k) clearance?

DEFIBRILLATOR ANALYZER - DA-2006P received FDA 510(k) clearance on 2011-02-08, under 510(k) number K110192.

Who is the listed applicant for DEFIBRILLATOR ANALYZER - DA-2006P?

The FDA 510(k) record lists Bc Group International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFIBRILLATOR ANALYZER - DA-2006P?

The FDA product code for DEFIBRILLATOR ANALYZER - DA-2006P is DRL.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DRL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190437Delta 3300Netech CorporationK182905UniPulseSeaward GroupK083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSFluke BiomedicalK072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, Inc.K030547MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBEGuardian Angel Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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