Fiberoptic Laryngoscope Handle

FDA 510(k) K944686 · Fiberoptic Medical Products, Inc.

Substantially Equivalent

510(k) numberK944686

Submission

Device name
Fiberoptic Laryngoscope Handle
Applicant
Fiberoptic Medical Products, Inc.
Allentown, PA, US
Received
September 23, 1994
Decision date
November 4, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Fiberoptic Laryngoscope Handle cleared by the FDA?

Fiberoptic Laryngoscope Handle (K944686) received a 510(k) decision of Substantially Equivalent on November 4, 1994, 42 days after the submission was received.

What is the product code of K944686?

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