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FDA 510(k)

PROPAQ 106(TM)

K-Number: K884320 · 1988-12-27

ApplicantProtocol Systems, Inc.
Decision Date1988-12-27
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROPAQ 106(TM) 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 1988-12-27 under 510(k) number K884320. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPAQ 106(TM)?

PROPAQ 106(TM) is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Protocol Systems, Inc.. The 510(k) number is K884320.

When did PROPAQ 106(TM) receive FDA 510(k) clearance?

PROPAQ 106(TM) received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884320.

Who is the listed applicant for PROPAQ 106(TM)?

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 106(TM)?

The FDA product code for PROPAQ 106(TM) is DRT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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