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FDA 510(k)

DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM

K-Number: K962613 · 1996-09-27

ApplicantGulmay Medical , Ltd.
Decision Date1996-09-27
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gulmay Medical , Ltd.. It received FDA 510(k) clearance on 1996-09-27 under 510(k) number K962613. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM?

DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Gulmay Medical , Ltd.. The 510(k) number is K962613.

When did DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM receive FDA 510(k) clearance?

DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM received FDA 510(k) clearance on 1996-09-27, under 510(k) number K962613.

Who is the listed applicant for DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM?

The FDA 510(k) record lists Gulmay Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM?

The FDA product code for DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM is JAD.

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Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

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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