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510(k) K974080

CRITIKON SOFT BLOOD PRESSURE CUFF by Johnson & Johnson Medical, Inc. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1998
Date Received
October 29, 1997
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.

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  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
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  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
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  • K973699 — ULTRALON POWDER FREE LATEX SURGICAL GLOVE (December 16, 1997)

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)
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