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FDA 510(k)

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER

K-Number: K954391 · 1995-11-17

ApplicantBio-Tek Instruments, Inc.
Decision Date1995-11-17
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1995-11-17 under 510(k) number K954391. 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 MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER?

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER is a medical device that received FDA 510(k) clearance on 1995-11-17. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K954391.

When did MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER receive FDA 510(k) clearance?

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER received FDA 510(k) clearance on 1995-11-17, under 510(k) number K954391.

Who is the listed applicant for MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER?

The FDA product code for MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER is DRL.

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Other records listing Bio-Tek Instruments, Inc. as applicant

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.

K973609IDA-4 AND IPT-MCK971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EFK961862MODELS IDA-2 PLUS AND IPT-1K953710ELX808 AUTOMATED MICROPLATE READERSK953572ELX800UVK950104ELX800 AND EL800 AUTOMATED MICROPLATE READERS

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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 GroupK110192DEFIBRILLATOR ANALYZER - DA-2006PBc Group International, Inc.K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSFluke BiomedicalK072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, Inc.

Official Source

View on FDA Database →

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

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