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FDA 510(k)

KEELER TEARSCOPE-PLUS

K-Number: K973064 · 1998-04-07

ApplicantKeeler Instruments, Inc.
Decision Date1998-04-07
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER TEARSCOPE-PLUS 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 1998-04-07 under 510(k) number K973064. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEELER TEARSCOPE-PLUS?

KEELER TEARSCOPE-PLUS is a medical device that received FDA 510(k) clearance on 1998-04-07. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K973064.

When did KEELER TEARSCOPE-PLUS receive FDA 510(k) clearance?

KEELER TEARSCOPE-PLUS received FDA 510(k) clearance on 1998-04-07, under 510(k) number K973064.

Who is the listed applicant for KEELER TEARSCOPE-PLUS?

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 KEELER TEARSCOPE-PLUS?

The FDA product code for KEELER TEARSCOPE-PLUS is HJO.

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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.

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Related Devices (Code: HJO)

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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.

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