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FDA 510(k)

PANORAMIC LOUPES - VARIOUS

K-Number: K841293 · 1984-05-09

ApplicantKeller Instruments, Inc.
Decision Date1984-05-09
Product CodeHLT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PANORAMIC LOUPES - VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Keller Instruments, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K841293. The device is classified under product code HLT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANORAMIC LOUPES - VARIOUS?

PANORAMIC LOUPES - VARIOUS is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Keller Instruments, Inc.. The 510(k) number is K841293.

When did PANORAMIC LOUPES - VARIOUS receive FDA 510(k) clearance?

PANORAMIC LOUPES - VARIOUS received FDA 510(k) clearance on 1984-05-09, under 510(k) number K841293.

Who is the listed applicant for PANORAMIC LOUPES - VARIOUS?

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

What is the FDA product code for PANORAMIC LOUPES - VARIOUS?

The FDA product code for PANORAMIC LOUPES - VARIOUS is HLT.

Related Clinical Trials

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Other records listing Keller 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.

K854541TIP OFF FORCEPSK841294ACU220 CRYO UNITK841292SPECTACLE INDIRECT OPHTHALMOSCOPEK823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

Related Devices (Code: HLT)

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.

K924277DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGChalgren Enterprises, Inc.K921815TOMEY PE-300 PORTABLE ERGTomey Corporation USAK781543ORBIOGRAPHSonometrics Systems, 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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