Home / 510(k) Clearances / K890795

510(k) K890795

RESPIRONICS SEALEASY II by Respironics, Inc. — Product Code BSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1989
Date Received
February 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Respironics, Inc.

  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K231313 — Therapy Mask 3100 NC/SP (July 28, 2023)
  • K210844 — DreamWear Silicone Pillows Mask (August 24, 2021)
  • K210386 — Magneto Nasal Mask (July 12, 2021)
  • K202142 — Sleepware G3 (October 29, 2020)
  • K201439 — Ventilator, Non-continuous (Respirator) (September 25, 2020)
  • K200480 — DreamStation 2 System, DreamStation 2 Advanced System (July 10, 2020)
  • K183226 — Care Orchestrator Essence (October 18, 2019)
  • K183625 — SomnaPatch (October 18, 2019)
  • K181170 — Trilogy Evo Universal (July 18, 2019)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)