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FDA 510(k)

PULSEMASTER S SERIES

K-Number: K943693 · 1994-08-22

ApplicantIncisive Technologies, Inc.
Decision Date1994-08-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSEMASTER S SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Incisive Technologies, Inc.. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K943693. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSEMASTER S SERIES?

PULSEMASTER S SERIES is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Incisive Technologies, Inc.. The 510(k) number is K943693.

When did PULSEMASTER S SERIES receive FDA 510(k) clearance?

PULSEMASTER S SERIES received FDA 510(k) clearance on 1994-08-22, under 510(k) number K943693.

Who is the listed applicant for PULSEMASTER S SERIES?

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

What is the FDA product code for PULSEMASTER S SERIES?

The FDA product code for PULSEMASTER S SERIES is GEX. This falls under the Gastroenterology category.

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Other records listing Incisive Technologies, 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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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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