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FDA 510(k)

SURETOUCH

K-Number: K980784 · 1998-04-29

ApplicantSahar Technologies, Inc.
Decision Date1998-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURETOUCH 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 1998-04-29 under 510(k) number K980784. 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 SURETOUCH?

SURETOUCH is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Sahar Technologies, Inc.. The 510(k) number is K980784.

When did SURETOUCH receive FDA 510(k) clearance?

SURETOUCH received FDA 510(k) clearance on 1998-04-29, under 510(k) number K980784.

Who is the listed applicant for SURETOUCH?

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 SURETOUCH?

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

Related Clinical Trials

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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.

K971024SOFTSCANK964684SOFTOUCH

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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