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510(k) K823262

MODEL SP5800 #8 FRENCH INTRO. KIT by Gould, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1983
Date Received
November 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Gould, Inc.

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  • K860805 — PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 (May 8, 1986)
  • K855145 — MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR (February 26, 1986)
  • K854403 — MODEL 2120 SPIROSCREEN (January 14, 1986)
  • K851486 — GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (October 17, 1985)
  • K850114 — C/PES 9201, ECG STRESS TESTING SYS (February 22, 1985)
  • K850113 — C/PES 9103, ECG STRESS TESTING SYSTEM (February 8, 1985)
  • K843555 — CARDIAC COMPUTER SP1445 (February 1, 1985)
  • K843969 — MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (January 23, 1985)

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