Home / 510(k) Clearances / K950771

510(k) K950771

DISPOSABLE ADHESIVE FACE MASK by Advanced Warming Systems, Inc. — Product Code BSJ

K950771 is an FDA 510(k) premarket notification submitted by Advanced Warming Systems, Inc. for the device "DISPOSABLE ADHESIVE FACE MASK". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Advanced Warming Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
February 21, 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 Advanced Warming Systems, Inc.

  • K953269 — SAFECIRCUIT MANIFOLD/PULMONARY UNIT (December 20, 1996)
  • K913016 — WARMTOUCH (September 4, 1991)

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)
  • 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