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510(k) K894973

RESPITRACE PLUS by Hogan & Hartson — Product Code FLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1989
Date Received
August 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

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  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)

Other clearances for product code FLS

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  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (January 12, 2000)
  • K962865 — REMBRANDT SYSTEM (October 25, 1996)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • K832999 — RESPIRATION MONITOR (February 13, 1984)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (October 6, 1982)
  • K821721 — CLINICAL DATA APNEA DETECTOR (July 13, 1982)
  • K820943 — SYSTEM I INFANT MONITORING SYS (May 3, 1982)
  • K810153 — VENTILATORY EFFORT MONITOR (February 9, 1981)