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FDA 510(k)

OSCAR 2, MODEL 222

K-Number: K003004 · 2000-10-25

ApplicantSuntech Medical Instruments, Inc.
Decision Date2000-10-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OSCAR 2, MODEL 222 is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical Instruments, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K003004. 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 OSCAR 2, MODEL 222?

OSCAR 2, MODEL 222 is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Suntech Medical Instruments, Inc.. The 510(k) number is K003004.

When did OSCAR 2, MODEL 222 receive FDA 510(k) clearance?

OSCAR 2, MODEL 222 received FDA 510(k) clearance on 2000-10-25, under 510(k) number K003004.

Who is the listed applicant for OSCAR 2, MODEL 222?

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

What is the FDA product code for OSCAR 2, MODEL 222?

The FDA product code for OSCAR 2, MODEL 222 is DXN.

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Other records listing Suntech Medical Instruments, 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.

K010622PRESSURE TRAK, MODEL 222-BK970629TANGO NON-INVASIVE BLOOD PRESSURE MONITORK9142604240 DYNAMIC BP/HEART RATE MONITORK913844ACCUTRACKER DX

Related Devices (Code: DXN)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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