FDA 510(k)

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A

K-Number: K801866 · 1980-09-16

ApplicantPentax Precision Instrument Corp.

Decision Date1980-09-16

Product CodeEQL

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801866. The device is classified under product code EQL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A?

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K801866.

When did PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A receive FDA 510(k) clearance?

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801866.

Who is the listed applicant for PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A?

The FDA 510(k) record lists Pentax Precision Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A?

The FDA product code for PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A is EQL.

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Other records listing Pentax Precision Instrument Corp. as applicant

K041397EG-3830UT K041396FG-36UX FIBER ULTRASOUND GASTROSCOPE K041395EG-3630UR K031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE K023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE K023376EB-1830T3, VIDEO BRONCHOSCOPE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.