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510(k) K915381

PORTABLE OXYGEN GENERATOR by Aequitron Medical, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Aequitron Medical, Inc.

  • K961972 — MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (April 18, 1997)
  • K952880 — MODEL LP-1000 VOLUME VENTILATOR (June 20, 1996)
  • K944654 — OXYGEN CONCENTRATION INDICATOR (November 8, 1994)
  • K914424 — MODEL 6213 REMOTE ALARM (September 10, 1992)
  • K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (September 19, 1991)
  • K903020 — RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (April 10, 1991)
  • K903010 — CONTINUOUS VOLUME VENTILATOR MODEL LP10 (November 30, 1990)
  • K905244 — MODEL LP6 VENTILATOR, MODIFICATION (November 30, 1990)
  • K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR (July 13, 1990)
  • K902785 — MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON (July 13, 1990)

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