INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S— 510(k) K011155

Name: FDA 510(k) clearance K011155
Creator: U.S. Food and Drug Administration
Published: 2001-07-12

Substantially Equivalent

Ibt, Inc.

FDA 510(k) clearance K011155 for INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S, Substantially Equivalent on 2001-07-12. Applicant: Ibt, Inc.. Device class: 2.

Clearance details

Applicant: Ibt, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2001-04-16
Decision date: 2001-07-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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