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510(k) K944157

DISPOSABLE, PREFORMED FACE MASK by Meridian Medical Systems, Inc. — Product Code BSJ

K944157 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, Inc. for the device "DISPOSABLE, PREFORMED FACE MASK". The FDA issued a decision of Substantially Equivalent on October 3, 1994. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Meridian Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
August 26, 1994
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 Meridian Medical Systems, Inc.

  • K162687 — Paragon 2 (October 21, 2016)
  • K143232 — Universal Digital Interface 2W, UDI 2W (January 30, 2015)
  • K140251 — UNIVERSAL DIGITAL INTERFACE 2, UDI 2 (October 22, 2014)
  • K112527 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (May 22, 2012)
  • K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (January 31, 2012)
  • K103599 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (April 27, 2011)
  • K945984 — MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS (December 27, 1994)

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)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)
  • K932014 — AMBU DISPOSABLE FACE MASK (June 22, 1993)

FDA data resources