Voyager/X

FDA 510(k) K884754 · Smith-Perry Corp.

Substantially Equivalent

510(k) numberK884754

Submission

Device name
Voyager/X
Applicant
Smith-Perry Corp.
Riviera Beach, FL, US
Received
November 14, 1988
Decision date
January 4, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
NFB – Conserver, Oxygen
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology

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K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special Inovo, Inc.12/08/2011SE
K103392Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special Inovo, Inc.12/17/2010SE
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K070740Chad Therapeutics Bonsai Model 800NFB · Special Chad Therapeutics, Inc.05/07/2007SE

More from Chad Therapeutics, Inc.

510(k)DeviceDecision
K895082Voyager PXBYJ · Traditional 01/09/1990SE

Questions and answers

When was Voyager/X cleared by the FDA?

Voyager/X (K884754) received a 510(k) decision of Substantially Equivalent on January 4, 1989, 51 days after the submission was received.

What is the product code of K884754?

The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.