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FDA 510(k)

MACHEMER/TANO ROTATING

K-Number: K833820 · 1984-01-04

Decision Date1984-01-04
Product CodeHRJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MACHEMER/TANO ROTATING is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1984-01-04 under 510(k) number K833820. The device is classified under product code HRJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACHEMER/TANO ROTATING?

MACHEMER/TANO ROTATING is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K833820.

When did MACHEMER/TANO ROTATING receive FDA 510(k) clearance?

MACHEMER/TANO ROTATING received FDA 510(k) clearance on 1984-01-04, under 510(k) number K833820.

Who is the listed applicant for MACHEMER/TANO ROTATING?

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

What is the FDA product code for MACHEMER/TANO ROTATING?

The FDA product code for MACHEMER/TANO ROTATING is HRJ.

Related Clinical Trials

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.

Other records listing Optical Micro Systems, 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.

View all 21 devices →

Related Devices (Code: HRJ)

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.

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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