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510(k) K201921

Spacelabs Lifescreen PRO Analyzer by Spacelabs Healthcare, Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
July 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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  • K150329 — elance Vital Signs Monitor, Central Monitor Software (November 5, 2015)
  • K141113 — SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE (September 26, 2014)
  • K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVER (September 9, 2014)
  • K130207 — SPACELABS HEALTHCARE CARDIOEXPRESS (July 23, 2013)
  • K122146 — XHIBIT CENTRAL STATION, MODEL 96102 (April 22, 2013)
  • K130112 — CAPNO MODULE, 92517 (March 21, 2013)
  • K121017 — CAPNOGRAPHY PAD (92516) (July 13, 2012)

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