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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120

Manufacturer

PALCO LABS, INC.

Date Cleared

2000-11-29

(83 days)

Product Code

DQA

Regulation Number

870.2700

Why did this record match?

Applicant Name (Manufacturer) :

PALCO LABS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

MODEL 120

Manufacturer

PALCO LABS, INC.

Date Cleared

2000-04-28

(123 days)

Product Code

DQA

Regulation Number

870.2700

Why did this record match?

Applicant Name (Manufacturer) :

PALCO LABS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Model 120 is intended to be used in the hospital, doctor's office, emergency medical facilities, or home care environments to measure %SpO2 and heart rate. The Model 120 is intended for use in short-term monitoring on adults and children.

Device Description

Not Found

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