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510(k) K881286

TEMPA-DOT CLINICAL THERMOMETER SHEATH by Pymah Corp. — Product Code FQZ

K881286 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "TEMPA-DOT CLINICAL THERMOMETER SHEATH". The FDA issued a decision of Substantially Equivalent on June 8, 1988. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900. Pymah Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1988
Date Received
March 25, 1988
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 Pymah Corp.

  • K952995 — ATI ETHYLENE OXIDE STERILIZATION INDICATOR (February 22, 1996)
  • K952408 — ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION (July 6, 1995)
  • K951063 — ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION (May 10, 1995)
  • K934874 — STERIGAGE EO 100% (April 18, 1995)
  • K943081 — TRIMLINE 2000 (January 27, 1995)
  • 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)

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)
  • K863181 — HEALTHCHECK THERM-STRIP (September 11, 1986)
  • 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