Mask, Pxygen

FDA 510(k) K781413 · Vitalab Products Corp.

Substantially Equivalent

510(k) numberK781413

Submission

Device name
Mask, Pxygen
Applicant
Vitalab Products Corp.
Mchenry, IL, US
Received
August 15, 1978
Decision date
September 7, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPT – Probe, Blood-Flow, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2120
Specialty
Cardiovascular

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More from Moor Instruments, Ltd.

510(k)DeviceDecision
K781416Tubing, Flexible, Medical GasBYX · Traditional 09/11/1978SE
K781415Cannula, Nasal, OxygenCAT · Traditional 09/07/1978SE
K781414Mask, Oxygen, NonbreathingKGB · Traditional 09/07/1978SE

Questions and answers

When was Mask, Pxygen cleared by the FDA?

Mask, Pxygen (K781413) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 23 days after the submission was received.

What is the product code of K781413?

The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.