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FDA 510(k)

TOMEY EM-1000 SPECULAR MICROSCOPE

K-Number: K944910 · 1994-11-22

ApplicantTomey Corporation USA
Decision Date1994-11-22
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOMEY EM-1000 SPECULAR MICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation USA. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944910. 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 TOMEY EM-1000 SPECULAR MICROSCOPE?

TOMEY EM-1000 SPECULAR MICROSCOPE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Tomey Corporation USA. The 510(k) number is K944910.

When did TOMEY EM-1000 SPECULAR MICROSCOPE receive FDA 510(k) clearance?

TOMEY EM-1000 SPECULAR MICROSCOPE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944910.

Who is the listed applicant for TOMEY EM-1000 SPECULAR MICROSCOPE?

The FDA 510(k) record lists Tomey Corporation USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMEY EM-1000 SPECULAR MICROSCOPE?

The FDA product code for TOMEY EM-1000 SPECULAR MICROSCOPE is HJO.

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Other records listing Tomey Corporation USA 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.

K971953CONFOSCANK971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMK961805TOMEY DTL ELECTRODEK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K924760TOMEY PROTON TONOMETER

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Related Devices (Code: HJO)

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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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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