PHASE 3, MODEL DT-1— 510(k) K062099

Substantially Equivalent

Datrend Systems, Inc.

FDA 510(k) clearance K062099 for PHASE 3, MODEL DT-1, Substantially Equivalent on 2007-01-25. Applicant: Datrend Systems, Inc.. Device class: 2.

Clearance details

Applicant: Datrend Systems, Inc.
Product code: Code DRL
Device class: Class 2
Regulation: 21 CFR 870.5325
Advisory panel: Cardiovascular
Date received: 2006-07-24
Decision date: 2007-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, British Columbia, CA

Download summary PDF View on FDA.gov ↗

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