EMS— 510(k) K931401

Substantially Equivalent

Saratoga Intl., Inc.

FDA 510(k) clearance K931401 for EMS, Substantially Equivalent on 1994-03-23. Applicant: Saratoga Intl., Inc.. Device class: 2.

Clearance details

Applicant: Saratoga Intl., Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1993-03-19
Decision date: 1994-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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