ERGOSEAT SYSTEM— 510(k) K954162

Substantially Equivalent

Ergo-Air, Inc.

FDA 510(k) clearance K954162 for ERGOSEAT SYSTEM, Substantially Equivalent on 1995-10-30. Applicant: Ergo-Air, Inc.. Device class: 2.

Clearance details

Applicant: Ergo-Air, Inc.
Product code: Code MOC
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1995-09-05
Decision date: 1995-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marblehead, MA, US

Download summary PDF View on FDA.gov ↗

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