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510(k) K071149

HRI 6500, 6600 AND 6700 SERIES V2MASKS by Hans Rudolph, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2008
Date Received
April 24, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Hans Rudolph, Inc.

  • 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)
  • 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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  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)