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FDA 510(k)

PULSEMASTER

K-Number: K961136 · 1996-06-03

ApplicantAmerican Dental Technologies, Inc.
Decision Date1996-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSEMASTER is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Technologies, Inc.. It received FDA 510(k) clearance on 1996-06-03 under 510(k) number K961136. 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?

PULSEMASTER is a medical device that received FDA 510(k) clearance on 1996-06-03. The listed applicant is American Dental Technologies, Inc.. The 510(k) number is K961136.

When did PULSEMASTER receive FDA 510(k) clearance?

PULSEMASTER received FDA 510(k) clearance on 1996-06-03, under 510(k) number K961136.

Who is the listed applicant for PULSEMASTER?

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

What is the FDA product code for PULSEMASTER?

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

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Other records listing American Dental 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.

K023547DIOLASE 980 D LASER SYSTEMK012127PULSEMASTER ERBIUM DENTAL LASER SYSTEMK012213GULLIVER AND CLASSE AK984486PULSEMASTER DENTAL LASER SYSTEMK972325PULSEMASTER 1000 ST DENTAL LASER SYSTEMK961269PULSEMASTER

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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