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510(k) K943081

TRIMLINE 2000 by Pymah Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1995
Date Received
June 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K925496 — ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K925745 — ATI(R) DISP BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K934180 — SLIMLINE 3000 (November 24, 1993)
  • K924681 — GLUTARALDEHYDE MONITORS (November 17, 1993)
  • K925744 — TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (July 30, 1993)
  • K930604 — BALANCED(TM) NYLON BLADDER (April 30, 1993)

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