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FDA 510(k)

DIGILAB MODULAR ONE-APPLANATION TONOMETER

K-Number: K863217 · 1986-09-24

ApplicantBio-Rad
Decision Date1986-09-24
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGILAB MODULAR ONE-APPLANATION TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1986-09-24 under 510(k) number K863217. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGILAB MODULAR ONE-APPLANATION TONOMETER?

DIGILAB MODULAR ONE-APPLANATION TONOMETER is a medical device that received FDA 510(k) clearance on 1986-09-24. The listed applicant is Bio-Rad. The 510(k) number is K863217.

When did DIGILAB MODULAR ONE-APPLANATION TONOMETER receive FDA 510(k) clearance?

DIGILAB MODULAR ONE-APPLANATION TONOMETER received FDA 510(k) clearance on 1986-09-24, under 510(k) number K863217.

Who is the listed applicant for DIGILAB MODULAR ONE-APPLANATION TONOMETER?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGILAB MODULAR ONE-APPLANATION TONOMETER?

The FDA product code for DIGILAB MODULAR ONE-APPLANATION TONOMETER is HKX.

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Related Devices (Code: HKX)

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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