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510(k) K881003

DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 by Healthcheck Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1988
Date Received
March 9, 1988
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

Other clearances by Healthcheck Corp.

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  • K874818 — TENSTAR (September 28, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (September 11, 1986)
  • K861946 — PTK PLUS. HOME PREGNANCY TEST (June 16, 1986)
  • K860287 — PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 (April 28, 1986)
  • K851379 — HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 (April 12, 1985)
  • K850070 — HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 (January 22, 1985)
  • K844281 — PTK HEALTHCHECK PREGNANCY TEST KIT (December 10, 1984)

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