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510(k) K940065

SES100 by Southwest Ergonomics — Product Code ISD

K940065 is an FDA 510(k) premarket notification submitted by Southwest Ergonomics for the device "SES100". The FDA issued a decision of Substantially Equivalent on December 6, 1994. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1994
Date Received
January 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)

FDA data resources