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FDA 510(k)

PRESSURE TRAK, MODEL 222-B

K-Number: K010622 · 2001-03-29

ApplicantSuntech Medical Instruments, Inc.
Decision Date2001-03-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE TRAK, MODEL 222-B 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 2001-03-29 under 510(k) number K010622. 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 PRESSURE TRAK, MODEL 222-B?

PRESSURE TRAK, MODEL 222-B is a medical device that received FDA 510(k) clearance on 2001-03-29. The listed applicant is Suntech Medical Instruments, Inc.. The 510(k) number is K010622.

When did PRESSURE TRAK, MODEL 222-B receive FDA 510(k) clearance?

PRESSURE TRAK, MODEL 222-B received FDA 510(k) clearance on 2001-03-29, under 510(k) number K010622.

Who is the listed applicant for PRESSURE TRAK, MODEL 222-B?

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 PRESSURE TRAK, MODEL 222-B?

The FDA product code for PRESSURE TRAK, MODEL 222-B 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.

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Related Devices (Code: DXN)

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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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