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510(k) K932147

NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE by Hans Rudolph, Inc. — Product Code BSJ

K932147 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE". The FDA issued a decision of Substantially Equivalent on August 20, 1993. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1993
Date Received
May 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
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)
  • 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)
  • K791705 — 4200 PNEUMATIC MOUTH SHUTTER (October 4, 1979)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932014 — AMBU DISPOSABLE FACE MASK (June 22, 1993)

FDA data resources