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510(k) K861260

PEDABAROGRAPH by Biokinetics, Inc. — Product Code JFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Pressure Measurement, Intermittent
Device Class
Class I
Regulation Number
890.1600
Review Panel
PM
Submission Type

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  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)
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  • K882139 — 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME (June 22, 1988)
  • K831800 — TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (August 16, 1983)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)