Delta T

FDA 510(k) K041076 · Penlon , Ltd.

Substantially Equivalent

510(k) numberK041076

Submission

Device name
Delta T
Applicant
Penlon , Ltd.
Abingdon, GB
Received
April 26, 2004
Decision date
August 9, 2004
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CAD – Vaporizer, Anesthesia, Non-Heated
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5880
Specialty
Anesthesiology

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Questions and answers

When was Delta T cleared by the FDA?

Delta T (K041076) received a 510(k) decision of Substantially Equivalent on August 9, 2004, 105 days after the submission was received.

What is the product code of K041076?

The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.