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510(k) K853515

PEE WEE THERMOMETERS by Joel R.L. Ehren Kranz — Product Code FQZ

K853515 is an FDA 510(k) premarket notification submitted by Joel R.L. Ehren Kranz for the device "PEE WEE THERMOMETERS". The FDA issued a decision of Substantially Equivalent on Oct 16, 1985. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900. Joel R.L. Ehren Kranz has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 16, 1985
Date Received
Aug 22, 1985
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 Joel R.L. Ehren Kranz

  • K844043 — OVUDATE (Feb 15, 1985)

Other clearances for product code FQZ

  • K110305 — CRY-ACTRACKERCAM (Jan 13, 2012)
  • K963049 — STERI-AID KIT (Nov 12, 1996)
  • K946046 — DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (Jul 19, 1995)
  • K894893 — POINT CHECKER COLOR STRIP THERMOMETER (Apr 5, 1990)
  • K884612 — FRANKLIN COLLECTOR(R) (Mar 27, 1989)
  • K881286 — TEMPA-DOT CLINICAL THERMOMETER SHEATH (Jun 8, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (Sep 11, 1986)
  • K822423 — BABY TEMP PACIFIER (Oct 13, 1982)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (Sep 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (Jun 27, 1979)

FDA data resources