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510(k) K202964

iBed Wireless with iBed Mobile by Stryker Corporation — Product Code FNL

K202964 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "iBed Wireless with iBed Mobile". The FDA issued a decision of Substantially Equivalent on June 18, 2021. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2021
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Ac-Powered Adjustable Hospital
Device Class
Class II
Regulation Number
880.5100
Review Panel
HO
Submission Type

Other clearances by Stryker Corporation

  • K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management Sys (August 18, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)
  • K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker an (February 16, 2023)
  • K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ A (October 19, 2022)
  • K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Devic (September 16, 2022)
  • K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele (July 12, 2022)
  • K213824 — Sonopet iQ Ultrasonic Aspirator System (February 3, 2022)
  • K212055 — Connected OR Hub with Device and Voice Control (December 16, 2021)
  • K210377 — Stryker iBur hubs and cutting accessories (June 30, 2021)
  • K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Numb (June 9, 2021)

Other clearances for product code FNL

  • K103536 — IBED WIRELESS WITH IBED AWARENESS (December 16, 2010)
  • K982783 — VAIL 1000 ENCLOSED BED (October 5, 1998)
  • K974296 — MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (January 6, 1998)
  • K974254 — BENEFIT B3--- SERIES (December 16, 1997)
  • K972115 — VOLKER HOSPITAL BED, MODEL K960 (August 29, 1997)
  • K971546 — SOMA 900 TRANSPORT BED (July 10, 1997)
  • K963622 — VAIL 2000 ENCLOSED BED (May 7, 1997)
  • K963589 — VAIL 3000 BED ENCLOSURE (April 21, 1997)
  • K962942 — TOTALCARE (February 3, 1997)
  • K963701 — SOMA SAFE ENCLOSURE (January 24, 1997)

FDA data resources