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510(k) K920206

POSEY SITTER by J. T. Posey Co. — Product Code KMI

K920206 is an FDA 510(k) premarket notification submitted by J. T. Posey Co. for the device "POSEY SITTER". The FDA issued a decision of Substantially Equivalent on May 14, 1992. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. J. T. Posey Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1992
Date Received
January 16, 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 by J. T. Posey Co.

  • K113355 — POSEY BED (May 2, 2012)
  • K113357 — POSEY BED (March 21, 2012)
  • K103817 — POSEY BED (April 22, 2011)
  • K963436 — RESTRAINT ACCESSORIES (November 22, 1996)
  • K963410 — POSEY STRAIGHT JACKETS (November 22, 1996)
  • K963414 — MULTIPLE BELTS (November 22, 1996)
  • K963442 — JACKETS AND VESTS (November 22, 1996)
  • K963411 — POSEY LAPTOP TRAYS (November 19, 1996)
  • K963439 — PEDIATRIC LIMB HOLDERS (November 19, 1996)
  • K963437 — PELVIC HOLDERS (November 19, 1996)

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