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510(k) K881393

RONDEX RESCUE MASK by Rondex Products, Inc. — Product Code BSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1988
Date Received
April 4, 1988
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 Rondex Products, Inc.

  • K981169 — RONDEX CPR ISO-SHIELD (May 19, 1998)
  • K942671 — CPR SHIELD (February 7, 1995)
  • K943761 — NON-BREATHING VALVE (November 10, 1994)
  • K921002 — RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED (October 6, 1992)
  • K914195 — RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED (November 8, 1991)
  • K914196 — RONDEX MASKS MODELS 9015/9011/901102 MODIFIED (November 8, 1991)
  • K902299 — CPR VALVE (NON-REBREATHING) MODEL #9030 (October 26, 1990)
  • K902298 — ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (August 22, 1990)
  • K881931 — RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (July 21, 1988)
  • K834250 — RESCUE MASK (January 18, 1984)

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)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)