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510(k) K962865

REMBRANDT SYSTEM by Airsep Corp. — Product Code FLS

K962865 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "REMBRANDT SYSTEM". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on Oct 25, 1996. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Airsep Corp. has 17 other 510(k) clearances on record.

Clearance Details

Decision
ST (Substantially Equivalent - Subject to Tracking Reg.)
Decision Date
Oct 25, 1996
Date Received
Jul 23, 1996
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 Airsep Corp.

  • K101154 — CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L (Mar 28, 2011)
  • K080348 — OXISCAN II DATA MANAGEMENT SYSTEM (Oct 9, 2008)
  • K020324 — LIFESTYLE OXYGEN CONCENTRATOR (Mar 13, 2002)
  • K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (Jan 17, 2002)
  • K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS (Oct 20, 2000)
  • K001579 — IMPULSE SELECT (Aug 31, 2000)
  • K001467 — DA VINCHI EMG/EP ISA1004EP (Aug 1, 2000)
  • K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (May 16, 2000)
  • K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (Aug 27, 1999)
  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (Oct 16, 1998)

Other clearances for product code FLS

  • K011597 — SMARTMONITOR 2, MODEL 4000 (Jan 11, 2002)
  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (Jan 12, 2000)
  • 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)
  • K810153 — VENTILATORY EFFORT MONITOR (Feb 9, 1981)

FDA data resources