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510(k) K945440

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK by Fvtnks — Product Code BSJ

K945440 is an FDA 510(k) premarket notification submitted by Fvtnks for the device "DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK". The FDA issued a decision of Substantially Equivalent on November 8, 1994. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Fvtnks has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1994
Date Received
November 7, 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 Fvtnks

  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K940544 — DOUBLE TRACH SEIVEL CONNECTOR (April 19, 1994)
  • K935713 — WILEY/ESPOSITO DENTAL GUARD (January 5, 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)
  • 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