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FDA 510(k)

PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO

K-Number: K123048 · 2013-01-11

ApplicantAdvanced Instrumentations, Inc.
Decision Date2013-01-11
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2013-01-11 under 510(k) number K123048. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO?

PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K123048.

When did PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO receive FDA 510(k) clearance?

PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO received FDA 510(k) clearance on 2013-01-11, under 510(k) number K123048.

Who is the listed applicant for PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO?

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

What is the FDA product code for PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO?

The FDA product code for PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO is MHX.

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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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