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510(k) K946077

DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS by Hans Rudolph, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
December 13, 1994
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 Hans Rudolph, Inc.

  • K071149 — HRI 6500, 6600 AND 6700 SERIES V2MASKS (February 1, 2008)
  • K030822 — 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS (June 3, 2003)
  • K030515 — HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS (May 2, 2003)
  • K020759 — 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, (August 13, 2002)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)
  • K791705 — 4200 PNEUMATIC MOUTH SHUTTER (October 4, 1979)

Other clearances for product code BZC

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  • K183567 — Vyntus/SentrySuite Product Line (August 23, 2019)
  • K190853 — Vyntus BODY (August 16, 2019)
  • 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)