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FDA 510(k)

POW-IR TIP

K-Number: K895073 · 1989-10-10

ApplicantLiving Technology, Inc.
Decision Date1989-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POW-IR TIP is the device name listed in this FDA 510(k) record. The listed applicant is Living Technology, Inc.. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K895073. 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 POW-IR TIP?

POW-IR TIP is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Living Technology, Inc.. The 510(k) number is K895073.

When did POW-IR TIP receive FDA 510(k) clearance?

POW-IR TIP received FDA 510(k) clearance on 1989-10-10, under 510(k) number K895073.

Who is the listed applicant for POW-IR TIP?

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

What is the FDA product code for POW-IR TIP?

The FDA product code for POW-IR TIP is GEX. This falls under the Gastroenterology category.

Other records listing Living Technology, 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.

K893956EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUMK885257EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNETK884682LIVING TECHNOLOGY LASER CONTACT TIPS

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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