FLOSENSE, MODEL 29-8010— 510(k) K990962

Substantially Equivalent

Sdi Diagnostics, Inc.

FDA 510(k) clearance K990962 for FLOSENSE, MODEL 29-8010, Substantially Equivalent on 2000-01-07. Applicant: Sdi Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sdi Diagnostics, Inc.
Product code: Code JAX
Device class: Class 2
Regulation: 21 CFR 868.2550
Advisory panel: Anesthesiology
Date received: 1999-03-22
Decision date: 2000-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Easton, MA, US

Download summary PDF View on FDA.gov ↗

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