Fiber Optic Laryngoscope

FDA 510(k) K883830 · Effner, Inc.

Substantially Equivalent

510(k) numberK883830

Submission

Device name
Fiber Optic Laryngoscope
Applicant
Effner, Inc.
Port Washington, NY, US
Received
September 9, 1988
Decision date
October 25, 1988
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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More from Arco Medic , Ltd.

510(k)DeviceDecision
K900680Effner Arthroperiscope/Arthroscope W/Remov. OpticsHRX · Traditional 03/29/1990SE
K882744Effner Illuminated Nasal Tracheostoma SpeculumEOB · Traditional 08/10/1988SE

Questions and answers

When was Fiber Optic Laryngoscope cleared by the FDA?

Fiber Optic Laryngoscope (K883830) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 46 days after the submission was received.

What is the product code of K883830?

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