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510(k) K903881

VENTLAB VENT-MASK, CAT# VR 0010/20/30 by Ventlab Corp. — Product Code BSJ

K903881 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB VENT-MASK, CAT# VR 0010/20/30". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Ventlab Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
August 22, 1990
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 Ventlab Corp.

  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • K102674 — CUFF SENTRY (July 22, 2011)
  • K093617 — VENTLAB 6000 SERIES HUMIDIFIER (January 27, 2011)
  • K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT (December 10, 2009)
  • K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (June 25, 2009)
  • K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD (August 13, 2008)
  • K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (March 26, 2008)
  • K040726 — VENTLAB NASAL CPAP CANNULA (June 3, 2004)
  • K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100 (July 7, 2003)

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)

FDA data resources