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FDA 510(k)

ES-100 POWER SYSTEM, ES-100 SERIES

K-Number: K925360 · 1993-09-07

ApplicantElekta Instruments, Inc.
Decision Date1993-09-07
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ES-100 POWER SYSTEM, ES-100 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instruments, Inc.. It received FDA 510(k) clearance on 1993-09-07 under 510(k) number K925360. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES-100 POWER SYSTEM, ES-100 SERIES?

ES-100 POWER SYSTEM, ES-100 SERIES is a medical device that received FDA 510(k) clearance on 1993-09-07. The listed applicant is Elekta Instruments, Inc.. The 510(k) number is K925360.

When did ES-100 POWER SYSTEM, ES-100 SERIES receive FDA 510(k) clearance?

ES-100 POWER SYSTEM, ES-100 SERIES received FDA 510(k) clearance on 1993-09-07, under 510(k) number K925360.

Who is the listed applicant for ES-100 POWER SYSTEM, ES-100 SERIES?

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

What is the FDA product code for ES-100 POWER SYSTEM, ES-100 SERIES?

The FDA product code for ES-100 POWER SYSTEM, ES-100 SERIES is GEY.

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Other records listing Elekta Instruments, 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.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEK955064SPETZLER TI 100 ANEURYSM CLIPK941823LEKSELL NEURO GENERATOR AND ACCESSORIESK946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEMK943468LEKSELL SURGIPLANK932261ES-100 ACCESSORIES

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Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., Inc.

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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