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510(k) K951043

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK by Promedic, Inc. — Product Code BSJ

K951043 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK". The FDA issued a decision of Substantially Equivalent on June 7, 1995. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1995
Date Received
March 7, 1995
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 Promedic, Inc.

  • K131889 — EUM 100PRO (April 23, 2014)
  • K112318 — CLEARPATH 24 (June 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K031409 — URINARY CATHETERS (June 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)

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)
  • 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)
  • K932014 — AMBU DISPOSABLE FACE MASK (June 22, 1993)

FDA data resources