SPECTURN, MODEL TTK-128— 510(k) K923180

Substantially Equivalent

Harpell Assoc., Inc.

FDA 510(k) clearance K923180 for SPECTURN, MODEL TTK-128, Substantially Equivalent on 1993-07-26. Applicant: Harpell Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Harpell Assoc., Inc.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1992-06-30
Decision date: 1993-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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