Home / 510(k) Clearances / K953107

510(k) K953107

ANESTHESIA/RESPIRATORY FACE MASK by Medical Marketing Concepts — Product Code BSJ

K953107 is an FDA 510(k) premarket notification submitted by Medical Marketing Concepts for the device "ANESTHESIA/RESPIRATORY FACE MASK". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Medical Marketing Concepts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
July 3, 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 Medical Marketing Concepts

  • K982215 — MANUAL RESUSCITATOR WITH ACE (September 18, 1998)
  • K961867 — PEEP VALVE (August 13, 1996)
  • K961329 — BAGRIGHT CHILD RESUSCITATOR (July 2, 1996)
  • K961330 — BAGRIGHT INFANT RESUSCITATOR (July 2, 1996)
  • K961868 — RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961882 — RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961369 — BAGRIGHT RESPOSABLE RESUSCITATOR (June 28, 1996)
  • K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K953546 — MANUAL PULMONARY RESUSICITATOR (February 29, 1996)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • 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)
  • K932014 — AMBU DISPOSABLE FACE MASK (June 22, 1993)

FDA data resources