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FDA 510(k)

MAKLAKOV STYLE TONOMETER

K-Number: K860330 · 1986-02-12

ApplicantMed-Tech Develoment Corp.
Decision Date1986-02-12
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAKLAKOV STYLE TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tech Develoment Corp.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K860330. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAKLAKOV STYLE TONOMETER?

MAKLAKOV STYLE TONOMETER is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Med-Tech Develoment Corp.. The 510(k) number is K860330.

When did MAKLAKOV STYLE TONOMETER receive FDA 510(k) clearance?

MAKLAKOV STYLE TONOMETER received FDA 510(k) clearance on 1986-02-12, under 510(k) number K860330.

Who is the listed applicant for MAKLAKOV STYLE TONOMETER?

The FDA 510(k) record lists Med-Tech Develoment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAKLAKOV STYLE TONOMETER?

The FDA product code for MAKLAKOV STYLE TONOMETER is HKY.

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.

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Other records listing Med-Tech Develoment Corp. 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.

K860852SAPPHIRE BLADE SURGICAL KNIFEK860332DIAMOND BLADE MICROMETER KNIFEK860331DISPOSABLE SURGICAL KNIFEK860329FYODOROV RADIAL KERATOTOMY MARKER SET

Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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