Home / 510(k) Clearances / K800164

510(k) K800164

413A NEONATAL MONITOR by Xerox Corp. — Product Code FLS

K800164 is an FDA 510(k) premarket notification submitted by Xerox Corp. for the device "413A NEONATAL MONITOR". The FDA issued a decision of Substantially Equivalent on Apr 10, 1980. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Xerox Corp. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 10, 1980
Date Received
Jan 25, 1980
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
510(k)

Other clearances by Xerox Corp.

  • K837513 — UNKNOWN (Jun 13, 1983)

Other clearances for product code FLS

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

FDA data resources