Series 2000 Meds Mask

FDA 510(k) K853785 · Med Systems

Substantially Equivalent

510(k) numberK853785

Submission

Device name
Series 2000 Meds Mask
Applicant
Med Systems
Santa Monica, CA, US
Received
September 10, 1985
Decision date
December 3, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
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

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K941145Oxy-GeneratorCAW · Traditional 09/27/1995SE

Questions and answers

When was Series 2000 Meds Mask cleared by the FDA?

Series 2000 Meds Mask (K853785) received a 510(k) decision of Substantially Equivalent on December 3, 1985, 84 days after the submission was received.

What is the product code of K853785?

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