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510(k) K030515

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS by Hans Rudolph, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2003
Date Received
February 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
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)
  • 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)
  • K946077 — DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS (September 15, 1995)
  • 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)

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