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510(k) K832999

RESPIRATION MONITOR by Litton Medical Electronics — Product Code FLS

K832999 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "RESPIRATION MONITOR". The FDA issued a decision of Substantially Equivalent on February 13, 1984. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Litton Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1984
Date Received
August 18, 1983
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 Litton Medical Electronics

  • K840522 — RECOMED BLOOD-FLOW METER H236-052-02 (May 16, 1985)
  • K840439 — RECOMED CARDIAC OUTPUT METER 236067- (November 20, 1984)
  • K840899 — SERVOMED ARRHYCOMP CENTRAL MONITOR SYS (November 20, 1984)
  • K840523 — SERVOMED PULSE AMPLIFIER MODULE-206- (October 29, 1984)
  • K840524 — SERVOMED BASIC BEDSIDE UNIT SMV 110TP (October 26, 1984)
  • K840832 — SERVOMED OXCARDIORE SPIROGRAPH 324/111 (September 20, 1984)
  • K840209 — SERVOMED MEDIVISION SCOPE SMV-235 (September 20, 1984)
  • K840525 — SERVOMED COMPACT MONITOR SMK 155-1/101 (June 1, 1984)
  • K832998 — 2-CHANNEL RECORDER (June 1, 1984)
  • K840521 — SERVOMED DIGITAL DISPLAY MODULE (June 1, 1984)

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)
  • 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)
  • K810153 — VENTILATORY EFFORT MONITOR (February 9, 1981)

FDA data resources