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510(k) K901251

MODEL 9101 RECORDER/ANALYZER SYSTEM by Aequitron Medical, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1990
Date Received
March 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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  • K914424 — MODEL 6213 REMOTE ALARM (September 10, 1992)
  • K915381 — PORTABLE OXYGEN GENERATOR (March 11, 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)

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