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FDA 510(k)

3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE

K-Number: K861749 · 1986-05-23

ApplicantKeeler Instruments, Inc.
Decision Date1986-05-23
Product CodeFSP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861749. The device is classified under product code FSP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE?

3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K861749.

When did 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE receive FDA 510(k) clearance?

3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861749.

Who is the listed applicant for 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE?

The FDA 510(k) record lists Keeler Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE?

The FDA product code for 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE is FSP.

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Other records listing Keeler Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: FSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K895248IMS5000 ILLUMINATED LOUPESLuxtec Corp.K891895SURGICAL LOUPESZinnanti Surgical Instruments, Inc.K864386LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.

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.

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