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510(k) K962517

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV by Healthdyne Technologies, Inc. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
June 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Non-Life-Supporting
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Healthdyne Technologies, Inc.

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  • K974879 — MODEL 7410 VOYAGER (June 29, 1998)
  • K972614 — TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 6 (January 20, 1998)
  • K971867 — ALICE 4R SYSTEM (August 13, 1997)
  • K971545 — PROTEGE LIQUID OXYGEN SYSTEM (July 25, 1997)
  • K970173 — MODEL 1700 TRANQUILITY BILEVEL SYSTEM (April 16, 1997)
  • K943509 — 7300 NASAL CPAP SYSTEM (August 5, 1994)

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