First Aid Kit(S)

FDA 510(k) K963298 · Vector, Inc.

Substantially Equivalent

510(k) numberK963298

Submission

Device name
First Aid Kit(S)
Applicant
Vector, Inc.
Orchard Park, NY, US
Received
August 21, 1996
Decision date
November 6, 1996
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
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
K931952Medway Oxygen MaskBYG · Traditional Medway08/20/1993SE
K924069Surgico Oxygen MaskBYG · Traditional Gujarat Surgico, Ltd.02/04/1993SE

More from Gujarat Surgico, Ltd.

510(k)DeviceDecision
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Questions and answers

When was First Aid Kit(S) cleared by the FDA?

First Aid Kit(S) (K963298) received a 510(k) decision of Substantially Equivalent on November 6, 1996, 77 days after the submission was received.

What is the product code of K963298?

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