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FDA 510(k)

TONOMITOR(TM)

K-Number: K870606 · 1987-04-10

ApplicantTonometrics Holdings SA C/O Mackeen Consultants
Decision Date1987-04-10
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TONOMITOR(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Tonometrics Holdings SA C/O Mackeen Consultants. It received FDA 510(k) clearance on 1987-04-10 under 510(k) number K870606. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONOMITOR(TM)?

TONOMITOR(TM) is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Tonometrics Holdings SA C/O Mackeen Consultants. The 510(k) number is K870606.

When did TONOMITOR(TM) receive FDA 510(k) clearance?

TONOMITOR(TM) received FDA 510(k) clearance on 1987-04-10, under 510(k) number K870606.

Who is the listed applicant for TONOMITOR(TM)?

The FDA 510(k) record lists Tonometrics Holdings SA C/O Mackeen Consultants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONOMITOR(TM)?

The FDA product code for TONOMITOR(TM) is FFT.

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Related Devices (Code: FFT)

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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