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510(k) K905421

EXIT ALARM by Alertcare — Product Code KMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1991
Date Received
December 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Bed Patient
Device Class
Class I
Regulation Number
880.2400
Review Panel
HO
Submission Type

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  • K942770 — ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (December 23, 1994)
  • K943481 — INFORMER PLUS (November 2, 1994)
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  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K940405 — TELETOM (April 14, 1994)