Medway Oxygen Mask

FDA 510(k) K931952 · Medway

Substantially Equivalent

510(k) numberK931952

Submission

Device name
Medway Oxygen Mask
Applicant
Medway
Franklin, TN, US
Received
April 20, 1993
Decision date
August 20, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BYG – Mask, Oxygen
Device class
Class I (low risk)
Regulation
21 CFR 868.5580
Specialty
Anesthesiology

Other 510(k)s with product code BYG

510(k)DeviceApplicantDecision
K963298First Aid Kit(S)BYG · Traditional Vector, Inc.11/06/1996SE
K962848Hans Rudolph Nasal CPAP MaskBYG · Traditional Hans Rudolph, Inc.10/16/1996SE
K945482Disposable, CPAP Oxygen MaskBYG · Traditional Fvtnks09/19/1995SE
K953464Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional Westmed, Inc.09/18/1995SE
K953039Various Adult & Child High Con/Nonrebreath Oxy MasksBYG · Traditional Dadsun Corp., Ltd.09/15/1995SE
K945472Westmed Pediatric and Adult Aerosol MaskBYG · Traditional Westmed Intl.02/07/1995SE
K942907Jemsdal MaskBYG · Traditional Respan Products, Inc.08/31/1994SE
K940888System 22 Paediatric MaskBYG · Traditional Medic-Aid , Ltd.04/19/1994SE
K940887System 22 Adult MaskBYG · Traditional Medic-Aid , Ltd.04/19/1994SE
K924069Surgico Oxygen MaskBYG · Traditional Gujarat Surgico, Ltd.02/04/1993SE

More from Gujarat Surgico, Ltd.

510(k)DeviceDecision
K934344Home Amb-AlertKMI · Traditional 04/29/1994SE
K911251Flex-IvFOZ · Traditional 10/28/1991SE
K911079Amb-AlertKMI · Traditional 09/13/1991SE
K910880Comfor-BoardKMK · Traditional 06/06/1991SE

Questions and answers

When was Medway Oxygen Mask cleared by the FDA?

Medway Oxygen Mask (K931952) received a 510(k) decision of Substantially Equivalent on August 20, 1993, 122 days after the submission was received.

What is the product code of K931952?

The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.