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510(k) K830778

MONITORING KIT AMK-1 by Alternative Design Systems, Inc. — Product Code FLS

K830778 is an FDA 510(k) premarket notification submitted by Alternative Design Systems, Inc. for the device "MONITORING KIT AMK-1". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Alternative Design Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
March 11, 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 Alternative Design Systems, Inc.

  • K874719 — STRATUM ESU (February 16, 1988)
  • K874697 — STRATUM D (December 15, 1987)
  • K854757 — 5000 SERIES ECG ELECTRODES (April 23, 1986)
  • K853633 — TENS CONDUCTIVE MEDIA PAD (December 3, 1985)
  • K852515 — ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR (June 24, 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)
  • 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