Medisize Gold

FDA 510(k) K052615 · Medisize BV

Substantially Equivalent

510(k) numberK052615

Submission

Device name
Medisize Gold
Applicant
Medisize BV
Hillegom, NL
Received
September 23, 2005
Decision date
December 9, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5450
Specialty
Anesthesiology

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More from Medline Industries, LP

510(k)DeviceDecision
K122885Medisize Gold Heater and Booster T-PieceBTT · Traditional 08/29/2013SE
K081536Medisize Blue, Medisize Green, Medisize RedCAH · Traditional 01/23/2009SE
K070714Medisize Gold Heater and BoosterBTT · Traditional 04/30/2007SE

Questions and answers

When was Medisize Gold cleared by the FDA?

Medisize Gold (K052615) received a 510(k) decision of Substantially Equivalent on December 9, 2005, 77 days after the submission was received.

What is the product code of K052615?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.