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FDA 510(k)

LOW-POWER BINOCULAR LOUPE

K-Number: K875124 · 1988-02-19

ApplicantSeiler Instrument & Mfg. Co., Inc.
Decision Date1988-02-19
Product CodeHOH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LOW-POWER BINOCULAR LOUPE is the device name listed in this FDA 510(k) record. The listed applicant is Seiler Instrument & Mfg. Co., Inc.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K875124. The device is classified under product code HOH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW-POWER BINOCULAR LOUPE?

LOW-POWER BINOCULAR LOUPE is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Seiler Instrument & Mfg. Co., Inc.. The 510(k) number is K875124.

When did LOW-POWER BINOCULAR LOUPE receive FDA 510(k) clearance?

LOW-POWER BINOCULAR LOUPE received FDA 510(k) clearance on 1988-02-19, under 510(k) number K875124.

Who is the listed applicant for LOW-POWER BINOCULAR LOUPE?

The FDA 510(k) record lists Seiler Instrument & Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW-POWER BINOCULAR LOUPE?

The FDA product code for LOW-POWER BINOCULAR LOUPE is HOH.

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Related Devices (Code: HOH)

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.

K934494SURGITELGeneral Scientific Corp.K810817EXETER OPERATING LOUPEExeter Instruments, Inc.

Official Source

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

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