Disposable, Anesthesia/Respiratory Face Mask

FDA 510(k) K945440 · Fvtnks

Substantially Equivalent

510(k) numberK945440

Submission

Device name
Disposable, Anesthesia/Respiratory Face Mask
Applicant
Fvtnks
Indianapolis, IN, US
Received
November 7, 1994
Decision date
November 8, 1994
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
K950771Disposable Adhesive Face MaskBSJ · Traditional Advanced Warming Systems, Inc.03/10/1995SE
K945894Mask, Gas, AnestheticBSJ · Traditional Hans Rudolph, Inc.01/27/1995SE
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
K945482Disposable, CPAP Oxygen MaskBYG · Traditional 09/19/1995SE
K940544Double Trach Seivel ConnectorBZA · Traditional 04/19/1994SE
K935713Wiley/Esposito Dental GuardBRW · Traditional 01/05/1994SE

Questions and answers

When was Disposable, Anesthesia/Respiratory Face Mask cleared by the FDA?

Disposable, Anesthesia/Respiratory Face Mask (K945440) received a 510(k) decision of Substantially Equivalent on November 8, 1994, 1 days after the submission was received.

What is the product code of K945440?

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