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FDA 510(k)

PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS

K-Number: K951246 · 1996-02-02

ApplicantProtocol Systems, Inc.
Decision Date1996-02-02
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS 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 1996-02-02 under 510(k) number K951246. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS?

PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K951246.

When did PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS receive FDA 510(k) clearance?

PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS received FDA 510(k) clearance on 1996-02-02, under 510(k) number K951246.

Who is the listed applicant for PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS?

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 ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS?

The FDA product code for PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS is FLS.

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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 STATIONK945071PROPAQ 200 MONITORK935846MODEL ACUITY CENTRAL STATIONK934711PROPAQ ECG TELEMETRY OPTIONK921497PROPAQ MONITORS, MODIFICATION

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Related Devices (Code: FLS)

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.

K011597SMARTMONITOR 2, MODEL 4000Respironics Georgia, Inc.K991087HANNAH WIRELESS VITAL SIGNS MONITORIlife Systems, Inc.K962865REMBRANDT SYSTEMAirsep Corp.K894973RESPITRACE PLUSHogan & HartsonK832999RESPIRATION MONITORLitton Medical ElectronicsK830778MONITORING KIT AMK-1Alternative Design Systems, Inc.

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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