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Found 3 results
510(k) Data Aggregation
K Number
K002725Device Name
MICROPAQ, MODELS 402 AND 404
Manufacturer
PROTOCOL SYSTEMS, INC.
Date Cleared
2000-11-21
(82 days)
Product Code
DRT
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
PROTOCOL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972121Device Name
ACUITY CENTRAL STATION
Manufacturer
PROTOCOL SYSTEMS, INC.
Date Cleared
1997-11-07
(155 days)
Product Code
MLD
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
PROTOCOL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.
Device Description
Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor
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K Number
K951246Device Name
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
Manufacturer
PROTOCOL SYSTEMS, INC.
Date Cleared
1996-02-02
(319 days)
Product Code
FLS, DRT, MHX
Regulation Number
868.2377Why did this record match?
Applicant Name (Manufacturer) :
PROTOCOL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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