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510(k) K191574

OxSAT 100 by S.L.P. , Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2020
Date Received
June 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by S.L.P. , Ltd.

  • K112822 — SLEEPSTRIP II (December 27, 2011)
  • K080375 — RMX PHYSIOLOGICAL DATA RECORDER (September 2, 2008)
  • K042253 — SLEEPSENSE SLEEP SENSORS (October 6, 2004)
  • K030869 — BITESTRIP (May 14, 2004)

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