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510(k) K991087

HANNAH WIRELESS VITAL SIGNS MONITOR by Ilife Systems, Inc. — Product Code FLS

K991087 is an FDA 510(k) premarket notification submitted by Ilife Systems, Inc. for the device "HANNAH WIRELESS VITAL SIGNS MONITOR". The FDA issued a decision of ST on January 12, 2000. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377.

Clearance Details

Decision
ST ()
Decision Date
January 12, 2000
Date Received
March 31, 1999
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

Other clearances for product code FLS

  • K011597 — SMARTMONITOR 2, MODEL 4000 (January 11, 2002)
  • K962865 — REMBRANDT SYSTEM (October 25, 1996)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • K894973 — RESPITRACE PLUS (October 30, 1989)
  • 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)

FDA data resources