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510(k) K810153

VENTILATORY EFFORT MONITOR by Medicon, Inc. — Product Code FLS

K810153 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "VENTILATORY EFFORT MONITOR". The FDA issued a decision of Substantially Equivalent on February 9, 1981. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1981
Date Received
January 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

Other clearances by Medicon, Inc.

  • K962087 — SERVOTRONIC EC100 SYSTEM (April 23, 1997)
  • K952168 — TITANIUM MANDIBULAR FRACTURE SYSTEM (June 22, 1995)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)

Other clearances for product code FLS

  • K011597 — SMARTMONITOR 2, MODEL 4000 (January 11, 2002)
  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (January 12, 2000)
  • K962865 — REMBRANDT SYSTEM (October 25, 1996)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • K894973 — RESPITRACE PLUS (October 30, 1989)
  • K832999 — RESPIRATION MONITOR (February 13, 1984)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (October 6, 1982)
  • K821721 — CLINICAL DATA APNEA DETECTOR (July 13, 1982)
  • K820943 — SYSTEM I INFANT MONITORING SYS (May 3, 1982)

FDA data resources