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FDA 510(k)

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

K-Number: K970429 · 1997-04-29

ApplicantApex Medical Corp.
Decision Date1997-04-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 1997-04-29 under 510(k) number K970429. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T?

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T is a medical device that received FDA 510(k) clearance on 1997-04-29. The listed applicant is Apex Medical Corp.. The 510(k) number is K970429.

When did BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T receive FDA 510(k) clearance?

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T received FDA 510(k) clearance on 1997-04-29, under 510(k) number K970429.

Who is the listed applicant for BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T?

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

What is the FDA product code for BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T?

The FDA product code for BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T is GZJ.

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Other records listing Apex Medical Corp. as applicant

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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