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FDA 510(k)

SOFTOUCH

K-Number: K964684 · 1997-02-14

ApplicantSahar Technologies, Inc.
Decision Date1997-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTOUCH 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 1997-02-14 under 510(k) number K964684. 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 SOFTOUCH?

SOFTOUCH is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Sahar Technologies, Inc.. The 510(k) number is K964684.

When did SOFTOUCH receive FDA 510(k) clearance?

SOFTOUCH received FDA 510(k) clearance on 1997-02-14, under 510(k) number K964684.

Who is the listed applicant for SOFTOUCH?

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 SOFTOUCH?

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

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.

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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.

K980784SURETOUCHK971024SOFTSCAN

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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