Effner-Saling Laryngoscope for New-Born

FDA 510(k) K844776 · Medical Instruments and Lamps

Substantially Equivalent

510(k) numberK844776

Submission

Device name
Effner-Saling Laryngoscope for New-Born
Applicant
Medical Instruments and Lamps
Port Washington, NY, US
Received
December 10, 1984
Decision date
October 1, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K062231MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special Minrad, Inc.08/31/2006SE
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Questions and answers

When was Effner-Saling Laryngoscope for New-Born cleared by the FDA?

Effner-Saling Laryngoscope for New-Born (K844776) received a 510(k) decision of Substantially Equivalent on October 1, 1985, 295 days after the submission was received.

What is the product code of K844776?

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