Disposable Adhesive Face Mask

FDA 510(k) K950771 · Advanced Warming Systems, Inc.

Substantially Equivalent

510(k) numberK950771

Submission

Device name
Disposable Adhesive Face Mask
Applicant
Advanced Warming Systems, Inc.
Lubbock, TX, US
Received
February 21, 1994
Decision date
March 10, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BSJ – Mask, Gas, Anesthetic
Device class
Class I (low risk)
Regulation
21 CFR 868.5550
Specialty
Anesthesiology

Other 510(k)s with product code BSJ

510(k)DeviceApplicantDecision
K163277SuperNO2VA DeviceBSJ · Traditional Revolutionary Medical Devices, Inc.10/13/2017SE
K953107Anesthesia/Respiratory Face MaskBSJ · Traditional Medical Marketing Concepts08/15/1995SE
K953295Anesthesia Face MaskBSJ · Traditional Mallinckrodt Medical08/11/1995SE
K952689Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional Owens-Brigam Medical Co.07/11/1995SE
K951043Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional Promedic, Inc.06/07/1995SE
K945894Mask, Gas, AnestheticBSJ · Traditional Hans Rudolph, Inc.01/27/1995SE
K945440Disposable, Anesthesia/Respiratory Face MaskBSJ · Traditional Fvtnks11/08/1994SE
K944157Disposable, Preformed Face MaskBSJ · Traditional Meridian Medical Systems, Inc.10/03/1994SE
K932147Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional Hans Rudolph, Inc.08/20/1993SE
K932014Ambu Disposable Face MaskBSJ · Traditional Ambu, Inc.06/22/1993SE

More from Ambu, Inc.

510(k)DeviceDecision
K953269Safecircuit Manifold/Pulmonary UnitCBN · Traditional 12/20/1996SE
K913016WarmtouchDWJ · Traditional 09/04/1991SE

Questions and answers

When was Disposable Adhesive Face Mask cleared by the FDA?

Disposable Adhesive Face Mask (K950771) received a 510(k) decision of Substantially Equivalent on March 10, 1995, 382 days after the submission was received.

What is the product code of K950771?

The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.