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FDA 510(k)

PROPAQ 102,104,106,102EL,104EL,&106EL

K-Number: K914838 · 1992-01-10

ApplicantProtocol Systems, Inc.
Decision Date1992-01-10
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROPAQ 102,104,106,102EL,104EL,&106EL is the device name listed in this FDA 510(k) record. The listed applicant is Protocol Systems, Inc.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914838. 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 PROPAQ 102,104,106,102EL,104EL,&106EL?

PROPAQ 102,104,106,102EL,104EL,&106EL is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K914838.

When did PROPAQ 102,104,106,102EL,104EL,&106EL receive FDA 510(k) clearance?

PROPAQ 102,104,106,102EL,104EL,&106EL received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914838.

Who is the listed applicant for PROPAQ 102,104,106,102EL,104EL,&106EL?

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

What is the FDA product code for PROPAQ 102,104,106,102EL,104EL,&106EL?

The FDA product code for PROPAQ 102,104,106,102EL,104EL,&106EL is MHX.

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Other records listing Protocol Systems, Inc. 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.

K002725MICROPAQ, MODELS 402 AND 404K972121ACUITY CENTRAL STATIONK951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSK945071PROPAQ 200 MONITORK935846MODEL ACUITY CENTRAL STATIONK934711PROPAQ ECG TELEMETRY OPTION

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Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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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