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510(k) K924433

SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 by Senior Technologies, Inc. — Product Code KMI

K924433 is an FDA 510(k) premarket notification submitted by Senior Technologies, Inc. for the device "SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
September 1, 1992
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 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