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510(k) K943509

7300 NASAL CPAP SYSTEM by Healthdyne Technologies, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
July 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Healthdyne Technologies, Inc.

  • K983572 — SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 (March 19, 1999)
  • K974453 — NASAL INTERFACE MODEL 7910 (August 4, 1998)
  • 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)
  • K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV (February 20, 1997)

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