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FDA 510(k)

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060

K-Number: K060820 · 2006-06-07

ApplicantSuntech Medical, Inc.
Decision Date2006-06-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical, Inc.. It received FDA 510(k) clearance on 2006-06-07 under 510(k) number K060820. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060?

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 is a medical device that received FDA 510(k) clearance on 2006-06-07. The listed applicant is Suntech Medical, Inc.. The 510(k) number is K060820.

When did CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 receive FDA 510(k) clearance?

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 received FDA 510(k) clearance on 2006-06-07, under 510(k) number K060820.

Who is the listed applicant for CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060?

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

What is the FDA product code for CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060?

The FDA product code for CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 is DXN.

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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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