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510(k) K012020

RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC by Non-Invasive Monitoring Systems, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2001
Date Received
June 28, 2001
Clearance Type
Special
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

Other clearances by Non-Invasive Monitoring Systems, Inc.

  • K001369 — RESPIEVENTS, VERSION 4.2 (July 26, 2000)
  • K942771 — RESPIEVENTS (February 13, 1996)
  • K942852 — RESPITRACE PT (February 13, 1996)
  • K903011 — RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL (March 29, 1991)
  • K884959 — RESPITRAK (June 8, 1989)

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