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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 ST on October 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
October 25, 1996
Date Received
July 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

Other clearances by Airsep Corp.

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

Other clearances for product code FLS

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

FDA data resources