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FDA 510(k)

SOFTSCAN

K-Number: K971024 · 1997-06-17

ApplicantSahar Technologies, Inc.
Decision Date1997-06-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Sahar Technologies, Inc.. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K971024. 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 SOFTSCAN?

SOFTSCAN is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Sahar Technologies, Inc.. The 510(k) number is K971024.

When did SOFTSCAN receive FDA 510(k) clearance?

SOFTSCAN received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971024.

Who is the listed applicant for SOFTSCAN?

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

What is the FDA product code for SOFTSCAN?

The FDA product code for SOFTSCAN is GEX. This falls under the Gastroenterology category.

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Other records listing Sahar 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.

K980784SURETOUCHK964684SOFTOUCH

Related Devices (Code: GEX)

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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