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FDA 510(k)

MINNILERT(R) PRESSURE MONITOR

K-Number: K913483 · 1991-09-27

ApplicantMinntech Corp.
Decision Date1991-09-27
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MINNILERT(R) PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K913483. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINNILERT(R) PRESSURE MONITOR?

MINNILERT(R) PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Minntech Corp.. The 510(k) number is K913483.

When did MINNILERT(R) PRESSURE MONITOR receive FDA 510(k) clearance?

MINNILERT(R) PRESSURE MONITOR received FDA 510(k) clearance on 1991-09-27, under 510(k) number K913483.

Who is the listed applicant for MINNILERT(R) PRESSURE MONITOR?

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

What is the FDA product code for MINNILERT(R) PRESSURE MONITOR?

The FDA product code for MINNILERT(R) PRESSURE MONITOR is KOC.

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K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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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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