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510(k) K220893

Strados Remote Electronic Stethoscope Platform (RESP) by Strados Labs, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2022
Date Received
March 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Strados Labs, Inc.

  • K201077 — Strados Remote Electronic Stethoscope Platform (RESP) (December 20, 2020)

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