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FDA 510(k)

SURGICAL IOP MONITOR

K-Number: K863235 · 1986-09-25

ApplicantAmeritek, Inc.
Decision Date1986-09-25
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGICAL IOP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1986-09-25 under 510(k) number K863235. 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 SURGICAL IOP MONITOR?

SURGICAL IOP MONITOR is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Ameritek, Inc.. The 510(k) number is K863235.

When did SURGICAL IOP MONITOR receive FDA 510(k) clearance?

SURGICAL IOP MONITOR received FDA 510(k) clearance on 1986-09-25, under 510(k) number K863235.

Who is the listed applicant for SURGICAL IOP MONITOR?

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

What is the FDA product code for SURGICAL IOP MONITOR?

The FDA product code for SURGICAL IOP MONITOR is HKX.

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Related Devices (Code: HKX)

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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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