Novamed MRI Conditional Laryngoscope Set

FDA 510(k) K063477 · Novamed, LLC

Substantially Equivalent

510(k) numberK063477

Submission

Device name
Novamed MRI Conditional Laryngoscope Set
Applicant
Novamed, LLC
Bonita Springs, FL, US
Received
November 16, 2006
Decision date
February 9, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCW – Laryngoscope, Rigid
Device class
Class I (low risk)
Regulation
21 CFR 868.5540
Specialty
Anesthesiology

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Questions and answers

When was Novamed MRI Conditional Laryngoscope Set cleared by the FDA?

Novamed MRI Conditional Laryngoscope Set (K063477) received a 510(k) decision of Substantially Equivalent on February 9, 2007, 85 days after the submission was received.

What is the product code of K063477?

The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.