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510(k) K925744

TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF by Pymah Corp. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1993
Date Received
November 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood Pressure Cuff
Device Class
Class II
Regulation Number
870.1120
Review Panel
CV
Submission Type

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

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)
  • K930604 — BALANCED(TM) NYLON BLADDER (April 30, 1993)

Other clearances for product code DXQ

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  • K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) (January 9, 2026)
  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
  • K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
  • K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
  • K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
  • K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
  • K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 (November 29, 2023)
  • K231961 — NIBPCuff (August 30, 2023)