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FDA 510(k)

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200

K-Number: K101002 · 2010-06-08

Decision Date2010-06-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 is the device name listed in this FDA 510(k) record. The listed applicant is Healthstats International Pte. , Ltd.. It received FDA 510(k) clearance on 2010-06-08 under 510(k) number K101002. 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 A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200?

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 is a medical device that received FDA 510(k) clearance on 2010-06-08. The listed applicant is Healthstats International Pte. , Ltd.. The 510(k) number is K101002.

When did A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 receive FDA 510(k) clearance?

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 received FDA 510(k) clearance on 2010-06-08, under 510(k) number K101002.

Who is the listed applicant for A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200?

The FDA 510(k) record lists Healthstats International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200?

The FDA product code for A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 is DXN.

Related Clinical Trials

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.

Other records listing Healthstats International Pte. , Ltd. 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.

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.

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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