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510(k) K771655

CURITY PEAKOMETER by Kendall Research Center — Product Code FFG

K771655 is an FDA 510(k) premarket notification submitted by Kendall Research Center for the device "CURITY PEAKOMETER". The FDA issued a decision of Substantially Equivalent on October 14, 1977. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. Kendall Research Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1977
Date Received
August 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K771079 — CURITY IRRIGATION TRAY (September 15, 1977)
  • K771563 — CONFORM ELASTIC NETTING (September 12, 1977)
  • K771452 — CONFORM STRETCH BANDAGE (5SIZES) (September 12, 1977)

Other clearances for product code FFG

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)

FDA data resources