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510(k) K863181

HEALTHCHECK THERM-STRIP by Healthcheck Corp. — Product Code FQZ

K863181 is an FDA 510(k) premarket notification submitted by Healthcheck Corp. for the device "HEALTHCHECK THERM-STRIP". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900. Healthcheck Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
August 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Color Change
Device Class
Class I
Regulation Number
880.2900
Review Panel
HO
Submission Type

Other clearances by Healthcheck Corp.

  • K884489 — C&T PREGNANCY TEST KIT (March 8, 1989)
  • K874818 — TENSTAR (September 28, 1988)
  • K881003 — DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 (May 18, 1988)
  • 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)

Other clearances for product code FQZ

  • K110305 — CRY-ACTRACKERCAM (January 13, 2012)
  • K963049 — STERI-AID KIT (November 12, 1996)
  • K946046 — DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (July 19, 1995)
  • K894893 — POINT CHECKER COLOR STRIP THERMOMETER (April 5, 1990)
  • K884612 — FRANKLIN COLLECTOR(R) (March 27, 1989)
  • K881286 — TEMPA-DOT CLINICAL THERMOMETER SHEATH (June 8, 1988)
  • K853515 — PEE WEE THERMOMETERS (October 16, 1985)
  • K822423 — BABY TEMP PACIFIER (October 13, 1982)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources