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510(k) K871203

BED PATIENT PRESENCE MONITOR by Human Technologies, Inc. — Product Code KMI

K871203 is an FDA 510(k) premarket notification submitted by Human Technologies, Inc. for the device "BED PATIENT PRESENCE MONITOR". The FDA issued a decision of Substantially Equivalent on May 26, 1987. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Human Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
March 25, 1987
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

Other clearances by Human Technologies, Inc.

  • K880639 — ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE (November 2, 1988)
  • K871158 — SIBIS REMOTE ACTUATOR (May 29, 1987)

Other clearances for product code KMI

  • K141877 — LEAF PATIENT MONITORING SYSTEM (November 10, 2014)
  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 2013)
  • K130752 — DYNASENSE SYSTEM (August 15, 2013)
  • K101109 — VIVATRAK (July 15, 2010)
  • K090138 — MOBILECARE MONITOR, MODEL 2100 (April 24, 2009)
  • K942770 — ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (December 23, 1994)
  • K943481 — INFORMER PLUS (November 2, 1994)
  • K933552 — PM-PAGER (September 22, 1994)
  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K940405 — TELETOM (April 14, 1994)

FDA data resources