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FDA 510(k)

PHASE 3, MODEL DT-1

K-Number: K062099 · 2007-01-25

ApplicantDatrend Systems, Inc.
Decision Date2007-01-25
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHASE 3, MODEL DT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Datrend Systems, Inc.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K062099. 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 PHASE 3, MODEL DT-1?

PHASE 3, MODEL DT-1 is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Datrend Systems, Inc.. The 510(k) number is K062099.

When did PHASE 3, MODEL DT-1 receive FDA 510(k) clearance?

PHASE 3, MODEL DT-1 received FDA 510(k) clearance on 2007-01-25, under 510(k) number K062099.

Who is the listed applicant for PHASE 3, MODEL DT-1?

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

What is the FDA product code for PHASE 3, MODEL DT-1?

The FDA product code for PHASE 3, MODEL DT-1 is DRL.

Related Clinical Trials

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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Other records listing Datrend Systems, 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.

K980165INFUTEST 2000 INFUSION DEVICE ANALYZER

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 BiomedicalK030547MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBEGuardian Angel Products, 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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