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510(k) K952542

ACKRAD ESOPHAGEAL BALLOON CATHETER SET by Ackrad Laboratories — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
May 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Ackrad Laboratories

  • K021272 — SIB CATHETER, MODEL 61-7005 (May 21, 2002)
  • K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TR (April 24, 2002)
  • K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (April 16, 2002)
  • K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (April 9, 1997)
  • K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 8, 1996)
  • K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (April 23, 1996)
  • K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 29, 1995)
  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K911780 — INFANT NASAL CANNULAE ASSEMBLY, MODIFIED (June 24, 1991)

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  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)